Apparatus and methods for forming and securing gastrointestinal tissue folds

ABSTRACT

Apparatus and methods are provided for forming a gastrointestinal tissue fold by engaging tissue at a first tissue contact point and moving the first tissue contact point from a position initially distal to, or in line with, a second tissue contact point to a position proximal of the second contact point, thereby forming the tissue fold, and extending an anchor assembly through the tissue fold from a vicinity of the second tissue contact point. Adjustable anchor assemblies; as well as anchor delivery systems, shape-lockable guides and methods for endoluminally performing medical procedures, such as gastric reduction, treatment of gastroesophageal reflux disease, resection of lesions, and treatment of bleeding sites; are also provided.

REFERENCE TO RELATED APPLICATIONS

[0001] This application is a Continuation-In-Part of U.S. patentapplication Ser. No. 10/672,375, filed Sep. 25, 2003, which claims thebenefit of the filing date of U.S. provisional patent application Ser.No. 60/500,627, filed Sep. 5, 2003; and is a Continuation-In-Part ofU.S. patent application Ser. No. 10/612,170, filed Jul. 1, 2003, andSer. No. 10/639,162, filed Aug. 11, 2003; both of which claim thebenefit of the filing date of U.S. provisional patent application Ser.No. 60/433,065, filed Dec. 11, 2002. Furthermore, this application is aContinuation-In-Part of U.S. patent application Ser. No. 10/173,203,filed Jun. 13, 2002; as well U.S. patent application Ser. No.10/458,060, filed Jun. 9, 2003, which is a Continuation-In-Part of U.S.patent application Ser. No. 10/346,709, filed Jan. 15, 2003, and whichclaims the benefit of the filing date of U.S. provisional patentapplication Ser. No. 60/471,893, filed May 19, 2003. Furtherstill, thisapplication is a Continuation-In-Part of U.S. patent application Ser.No. 10/288,619, filed Nov. 4, 2002; which is a Continuation-In-Part ofU.S. patent application Ser. No. 09/746,579, filed Dec. 20, 2000, and aContinuation-In-Part of co-pending, commonly assigned U.S. patentapplication Ser. No. 10/188,509, filed Jul. 3, 2002; which is aContinuation-In-Part of U.S. patent application Ser. No. 09/898,726,filed Jul. 3, 2001; which is a Continuation-In-Part of U.S. patentapplication Ser. No. 09/602,436, filed Jun. 23, 2000, which claims thebenefit of the filing date of U.S. provisional patent application Ser.No. 60/141,077, filed Jun. 25, 1999. All of these applications areincorporated herein by reference in their entireties.

FIELD OF THE INVENTION

[0002] The present invention relates to methods and apparatus forintraluminally forming and securing gastrointestinal (“GI”) tissuefolds. More particularly, the present invention relates to methods andapparatus for reducing the effective cross-sectional area of agastrointestinal lumen.

BACKGROUND OF THE INVENTION

[0003] Morbid obesity is a serious medical condition pervasive in theUnited States and other countries. Its complications includehypertension, diabetes, coronary artery disease, stroke, congestiveheart failure, multiple orthopedic problems and pulmonary insufficiencywith markedly decreased life expectancy.

[0004] Several surgical techniques have been developed to treat morbidobesity, e.g., bypassing an absorptive surface of the small intestine,or reducing the stomach size. These procedures are difficult to performin morbidly obese patients because it is often difficult to gain accessto the digestive organs. In particular, the layers of fat encountered inmorbidly obese patients make difficult direct exposure of the digestiveorgans with a wound retractor, and standard laparoscopic trocars may beof inadequate length.

[0005] In addition, previously known open surgical procedures maypresent numerous life-threatening post-operative complications, and maycause atypical diarrhea, electrolytic imbalance, unpredictable weightloss and reflux of nutritious chyme proximal to the site of theanastamosis. Further, the sutures or staples that are often used inthese surgical procedures may require extensive training by theclinician to achieve competent use, and may concentrate significantforce over a small surface area of the tissue, thereby potentiallycausing the suture or staple to tear through the tissue.

[0006] The gastrointestinal lumen includes four tissue layers, whereinthe mucosa layer is the top tissue layer followed by connective tissue,the muscularis layer and the serosa layer. One problem with conventionalgastrointestinal reduction systems is that the anchors (or staples) mustengage at least the muscularis tissue layer in order to provide a properfoundation. In other words, the mucosa and connective tissue layerstypically are not strong enough to sustain the tensile loads imposed bynormal movement of the stomach wall during ingestion and processing offood. In particular, these layers tend to stretch elastically ratherthan firmly hold the anchors (or staples) in position, and accordingly,the more rigid muscularis and/or serosa layer must be engaged. Thisproblem of capturing the muscularis or serosa layers becomesparticularly acute where it is desired to place an anchor or otherapparatus transesophageally rather than intraoperatively, since caremust be taken in piercing the tough stomach wall not to inadvertentlypuncture adjacent tissue or organs.

[0007] In view of the aforementioned limitations, it would be desirableto provide methods and apparatus for forming gastrointestinal tissuefolds that achieve gastric reduction by reconfiguring the GI lumen of apatient.

[0008] It would be desirable to provide methods and apparatus forforming gastrointestinal tissue folds using anchors that can bereconfigured from a reduced delivery profile to an expanded deployedprofile.

[0009] It also would be desirable to provide methods and apparatus forforming gastrointestinal tissue folds, wherein an anchor assembly isextended across stomach folds that include the muscularis and serosatissue layers.

[0010] It further would be desirable to provide methods and apparatusfor forming gastrointestinal tissue folds, wherein the anchor assemblyis deployed in a manner that reduces a possibility of injuringneighboring organs.

[0011] It still further would be desirable to provide methods andapparatus for forming gastrointestinal tissue folds, wherein reducedtraining of a clinician is required to achieve competent use of theanchor assembly.

[0012] It would be desirable to provide methods and apparatus forforming gastrointestinal tissue folds that facilitate approximation of aplurality of tissue folds.

SUMMARY OF THE INVENTION

[0013] In view of the foregoing, it is an object of the presentinvention to provide methods and apparatus for forming gastrointestinaltissue folds that achieve gastric reduction by reconfiguring the GIlumen of a patient.

[0014] It is another object of the present invention to provide methodsand apparatus for forming gastrointestinal tissue folds using anchorsthat can be reconfigured from a reduced delivery profile to an expandeddeployed profile.

[0015] It is an additional object of this invention to provide methodsand apparatus for forming gastrointestinal tissue folds in which ananchor assembly is extended across stomach folds that include themuscularis and serosa tissue layers.

[0016] It is a further object of the present invention to providemethods and apparatus for forming gastrointestinal tissue folds, whereinthe anchor assembly is deployed in a manner that reduces a possibilityof injuring neighboring organs.

[0017] It is yet another object to provide methods and apparatus forforming gastrointestinal tissue folds, wherein reduced training of aclinician is required to achieve competent use of the anchor assembly.

[0018] It is an object to provide methods and apparatus for forminggastrointestinal tissue folds that facilitate approximation of aplurality of tissue folds.

[0019] These and other objects of the present invention are accomplishedby providing a catheter configured for advancement into a patient'sgastrointestinal lumen to form a gastrointestinal tissue fold. In onepreferred embodiment, the catheter has a distal region including atissue grabbing assembly adapted to engage and/or stretch a portion ofthe tissue wall of the GI lumen at a first tissue contact point. Asecond tissue contact point is then established with the tissue wall ata location initially proximal of, or in line with, the first tissuecontact point. The tissue engaged by the tissue grabbing assembly thenis moved to a position proximal of the second tissue contact point toform a tissue fold, and one or more anchor assemblies may be deliveredacross the tissue fold. Preferably, delivery of the anchor assemblyacross the tissue fold includes delivering the anchor assembly acrossthe muscularis and serosa layers of the tissue wall.

[0020] Optionally, a third tissue contact point may be established atanother location initially proximal of, or in line with, the firsttissue contact point. Upon movement of the tissue engaged by the tissuegrabbing assembly to a position proximal of both the second and thirdtissue contact points, a tissue fold is formed with the second and thirdcontact points on opposing sides of the fold. The third contact pointmay provide backside stabilization upon delivery of the anchor assemblyacross the tissue fold from a vicinity of the second tissue contactpoint.

[0021] In a preferred embodiment, the tissue grabbing assembly iscarried on a first flexible tube associated with the distal region ofthe catheter, and the one or more anchor assemblies are delivered by ananchor delivery system disposed within a second flexible tube associatedwith the distal region of the catheter. The tissue grabbing assembly maycomprise any of a number of mechanisms configured to engage the tissuewall, including a pair of jaws configured to move between open andclosed positions, a plurality of linearly translating barbs, a coilscrew, or one or more needles or hooks. The first tissue contact pointmay be moved from a tissue engagement position distal to, or in linewith, the second tissue contact point, to the tissue folding position byany of a number of mechanisms, including a hinge assembly, a treadmillassembly, or a linear pull assembly.

[0022] More preferably, the distal region of the catheter includes abendable section that permits the first tissue contact point to bepositioned relative to the second tissue contact point so that thetissue fold is oriented substantially perpendicular to the anchordelivery system. In this manner, the anchor delivery system, whendeployed, pierces the tissue fold and exits into the interior of the GIlumen, rather than the exterior of the tissue wall, thereby reducing arisk of injury to adjacent organs.

[0023] The anchor assembly delivery system of the present inventionpreferably comprises a needle or obturator adapted to pierce the tissuefold and deliver an anchor assembly. In one preferred embodiment, theanchor assembly comprises a pair of rod-like anchors that are deliveredthrough a needle in a reduced delivery profile, wherein the longitudinalaxis of the rods is substantially parallel to the longitudinal axis ofthe needle. Once ejected from the needle, the rods rotate about 90degrees to engage the tissue. In other embodiments, the anchor assemblymay comprise anchors of various shapes delivered, for example, over theexterior of an obturator.

[0024] In a preferred embodiment of the present invention, the catheteris adapted to form a plurality of gastrointestinal tissue folds that maybe approximated. Optionally, an anchor assembly may be placed acrosseach tissue fold, and the plurality of tissue folds then may beapproximated by cinching the plurality of anchor assemblies together.Alternatively, an anchor assembly may be placed across a plurality oftissue folds, and the plurality of tissue folds may be approximated bycinching the anchor assembly. As yet another alternative, a plurality oftissue folds may be approximated prior to placement of an anchorassembly. One or more anchor assemblies then may be placed across theapproximated plurality of tissue folds to secure the plurality in theapproximated position. Multiple pluralities of tissue folds may bejoined together and/or approximated in order to perform a procedure, forexample, a gastric reduction or treatment of gastroesophageal refluxdisease (“GERD”).

[0025] To facilitate proper positioning, as well as visualization, ofthe tools and instruments of the present invention at a treatment sitewithin a tortuous lumen or within unpredictably supported anatomy, ashape-lockable guide may be provided having a flexible state andreversibly rigidizable state. This guide may comprise an overtubethrough which instruments of the present invention, as well as anendoscope, may be advanced. As described hereinafter, exemplaryprocedures achievable when using tools of the present invention inconjunction with an endoscope include, for example, endoluminal gastricreduction and endoluminal treatment of GERD.

[0026] Methods of using the apparatus of the present invention also areprovided.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above and other objects and advantages of the presentinvention will be apparent upon consideration of the following detaileddescription, taken in conjunction with the accompanying drawings, inwhich like reference characters refer to like parts throughout, and inwhich:

[0028]FIGS. 1A and 1B are, respectively, a side view and detail view ofapparatus of the present invention for forming a gastrointestinal foldin accordance with the principles of the present invention;

[0029]FIGS. 2A and 2B are side-sectional views of a tissue grabbingassembly suitable for use with the apparatus of FIGS. 1;

[0030]FIGS. 3A-3E are side views illustrating a method of using theapparatus of FIGS. 1 to form a gastrointestinal fold;

[0031]FIGS. 4A-4C are side-sectional views of an anchor assembly anddelivery system suitable for use with apparatus of the presentinvention;

[0032]FIGS. 5A and 5B are side-sectional views of another anchorassembly suitable for use with apparatus of the present invention;

[0033]FIGS. 6A and 6B are side-sectional views of another alternativeanchor assembly suitable for use with apparatus of the presentinvention;

[0034]FIGS. 7A-7C are, respectively, a schematic side-sectional view ofa unidirectionally adjustable anchor assembly suitable for use withapparatus of the present invention, schematic side-sectional views ofalternative techniques for fixing the distal anchor of the assembly, anda cross-sectional view of the proximal anchor taken along section lineA—A of FIG. 7A;

[0035]FIGS. 8A and 8B are schematic cross-sectional views illustratingthe unidirectional adjustment capability of the anchor assembly of FIGS.7;

[0036]FIGS. 9A-9C are schematic cross-sectional views of alternativeembodiments of the proximal anchor of the anchor assembly of FIGS. 7;

[0037]FIGS. 10A and 10B are schematic cross-sectional views of analternative unidirectionally adjustable anchor assembly suitable for usewith apparatus of the present invention;

[0038]FIGS. 11A-11C are, respectively, a schematic side-view of anotheralternative unidirectionally adjustable anchor assembly suitable for usewith the present invention, and cross-sectional views of the same takenalong section line B—B of FIG. 11A;

[0039]FIG. 12 is a schematic cross-sectional view of an alternativeunidirectionally adjustable anchor assembly comprising pivoting paddles;

[0040]FIG. 13 is a schematic cross-sectional view of an alternativeunidirectionally adjustable anchor assembly comprising spring material;

[0041]FIGS. 14A-14B are schematic side-sectional views of alternativeunidirectionally adjustable anchor assemblies comprising one-way valves;

[0042]FIGS. 15A-15C are side-sectional and detail views of alternativeunidirectionally adjustable anchor assemblies comprising slipknots;

[0043]FIGS. 16A-16C are, respectively, a schematic side-sectional viewof a bi-directionally adjustable anchor assembly comprising a lockingmechanism, and cross-sectional views of the same taken along sectionline C—C of FIG. 16A;

[0044]FIGS. 17A-17D are perspective views of alternative anchorssuitable for use with the anchor assemblies of the present invention;

[0045]FIGS. 18A-18D are side views of alternative apparatus for forminga gastrointestinal fold;

[0046]FIG. 19 is a cross-sectional view of the apparatus of FIGS.18A-18D;

[0047]FIGS. 20A-20D are side views of further alternative apparatus forforming a gastrointestinal tissue fold in accordance with the principlesof the present invention;

[0048]FIGS. 21A-21G are schematic side-sectional views of an anchordelivery system adapted for use with the adjustable anchor assemblies ofFIGS. 7-17, illustrating a method of delivering the unidirectionallyadjustable anchor assembly of FIGS. 7 across a tissue fold;

[0049]FIGS. 22A and 22B are, respectively, a schematic side-view,partially in section, and an end-view of an alternative anchor deliverysystem adapted for use with the adjustable anchor assemblies of FIGS.7-17, wherein the proximal anchor is disposed within a separate deliverytube;

[0050]FIG. 23 is a schematic side-sectional view of an alternativeanchor delivery system adapted for use with the adjustable anchorassemblies of FIGS. 7-17, wherein both the proximal and distal anchorsare loaded within the needle;

[0051]FIG. 24 is a schematic side-sectional view of an alternativeembodiment of the anchor delivery system of FIG. 23 comprising motionlimitation apparatus;

[0052]FIG. 25 is a schematic side view, partially in section of analternative anchor delivery system adapted to deliver a plurality ofanchor assemblies;

[0053]FIG. 26 is a schematic side view of an alternative embodiment ofthe anchor delivery system of FIG. 25;

[0054]FIGS. 27A and 27B are, respectively, schematic isometric and sideviews, partially in section, of an alternative anchor delivery systemadapted to deliver a plurality of anchor assemblies via a revolver;

[0055]FIGS. 28A and 28B are side views of an alternative embodiment ofthe apparatus of FIGS. 20 illustrating a method for simultaneouslyforming and approximating multiple gastrointestinal tissue folds;

[0056]FIG. 29 is an isometric view of an alternative embodiment of theapparatus of FIGS. 1 for forming a gastrointestinal tissue foldcomprising backside stabilization;

[0057]FIGS. 30A-30E are a side view, partially in section, and isometricviews illustrating a method of using the apparatus of FIG. 29 to form abackside stabilized gastrointestinal tissue fold;

[0058]FIGS. 31A-31C are side views of further alternative tissue foldingapparatus illustrating a method for forming a gastrointestinal tissuefold via a linear displacement of tissue;

[0059]FIG. 32 is a side view of an alternative embodiment of theapparatus of FIG. 31 providing enhanced flexibility;

[0060]FIGS. 33A and 33B are side views of further alternative front andbackside stabilized linear displacement plication apparatus,illustrating a method for forming a gastrointestinal tissue fold;

[0061]FIGS. 34A and 34B are, respectively, a side view and a side view,partially in section, of still further alternative apparatusillustrating a method for forming a stabilized gastrointestinal tissuefold via a braided mesh;

[0062]FIG. 35 is a side view of illustrative shape-lockable apparatusfor use with the tissue folding and anchor delivery apparatus of thepresent invention;

[0063]FIG. 36 is a side-sectional exploded view of nestable elements ofa first embodiment of an overtube suitable for use with theshape-lockable apparatus of FIG. 35;

[0064]FIG. 37 is a side-sectional view of a distal region of theapparatus of FIG. 35 constructed in accordance with principles of thepresent invention;

[0065]FIG. 38 is a side-sectional view of an illustrative arrangement ofa mechanism suitable for use in the handle of the apparatus of FIG. 35;

[0066]FIG. 39 is a side-sectional view of the detail of a wire clampingsystem suitable for use in the handle of FIG. 35;

[0067]FIGS. 40A-40D are side-views, partially in section, illustratingan exemplary method of performing endoluminal gastric reduction with asystem of tools illustratively comprising the shape-lockable apparatusof FIGS. 35-39, the plication apparatus of FIGS. 1-3, the anchorassembly of FIGS. 7, the anchor delivery system of FIGS. 21 and acommercially available gastroscope;

[0068]FIGS. 41A-41C are, respectively, an isometric view of a patient'sstomach after performing endoluminal gastric reduction using the methodsof FIG. 40; a cross-sectional view of the same along plane A—A in FIG.41A; and a cross-sectional view of the stomach along plane B—B in FIG.41A, prior to approximation of the pluralities of tissue folds toachieve the gastric reduction;

[0069]FIGS. 42A-42C are side-views, partially in section, illustratingan exemplary method of treating gastroesophageal reflux disease with theillustrative system of tools described with respect to FIGS. 40;

[0070]FIGS. 43A and 43B are side-views, partially in section,illustrating an alternative method of performing endoluminal gastricreduction utilizing a system of tools of the present invention;

[0071]FIG. 44 is a side view, partially in section, illustrating amethod of resecting a lesion or early cancer utilizing a system of toolsof the present invention illustratively comprising a suction plicatorand a resection loop; and

[0072]FIG. 45 is a side view, partially in section, illustrating amethod of treating a bleeding site utilizing a system of tools of thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

[0073] In accordance with the principles of the present invention,methods and apparatus are provided for intraluminally forming andsecuring gastrointestinal (“GI”) tissue folds, for example, to reducethe effective cross-sectional area of a GI lumen. These methods andapparatus may be used to treat obesity by approximating the walls of agastrointestinal lumen to narrow the lumen, thus reducing the area forabsorption in the stomach or intestines. More particularly, the presentinvention involves endoscopic apparatus that engages a tissue wall ofthe gastrointestinal lumen, creates one or more tissue folds anddisposes one or more anchor assemblies through the tissue fold(s).Preferably, the anchor assemblies are disposed through the muscularisand/or serosa layers of the gastrointestinal lumen. In operation, adistal tip of the probe engages the tissue and then moves the engagedtissue to a proximal position relative to the catheter tip, therebyproviding a substantially uniform plication of predetermined size.

[0074] Formation of a tissue fold preferably is accomplished using atleast two tissue contact points that are separated by a linear orcurvilinear distance, wherein the separation distance between the tissuecontact points affects the length and/or depth of the fold. Inoperation, a tissue grabbing assembly engages the tissue wall in itsnormal state (i.e., non-folded and substantially flat), thus providing afirst tissue contact point. The first tissue contact point then is movedto a position proximal of a second tissue contact point to form thetissue fold. An anchor assembly then may be extended across the tissuefold at the second tissue contact point. Optionally, a third tissuecontact point may be established such that, upon formation of the tissuefold, the second and third tissue contact points are disposed onopposing sides of the tissue fold, thereby providing backsidestabilization during extension of the anchor assembly across the tissuefold from the second tissue contact point.

[0075] Preferably, the first tissue contact point is used to engage andthen stretch or rotate the tissue wall over the second tissue contactpoint to form the tissue fold. The tissue fold is then articulated to aposition wherein a portion of the tissue fold overlies the second tissuecontact point at an orientation that is substantially normal to thetissue fold. An anchor then is delivered across the tissue fold at ornear the second tissue contact point.

[0076] Referring to FIGS. 1, apparatus 10 of the present inventioncomprises torqueable catheter 11 having distal region 12 from whichfirst and second interconnected flexible tubes 13 and 14 extend, andproximal region 15 having handle 16 and actuator 17. Catheter 11 isconfigured for insertion through a patient's mouth and esophagus intothe gastrointestinal lumen. Tissue grabbing assembly 18 is disposed onthe distal end of flexible tube 13, and is coupled to actuator 17 viacontrol wire 19 that extends through flexible tube 13.

[0077] As better illustrated in FIG. 1B, flexible tubes 13 and 14 areconnected via hinge assembly 20 that comprises link 21 attached toflexible tube 13 at pivot point 22 and attached to flexible tube 14 atpivot point 23. Hinge assembly 20 prevents tissue grabbing assembly 18from moving more than a predetermined distance relative to distal end 24of flexible tube 14.

[0078] Still referring to FIG. 1B, flexible tubes 13 and 14 preferablyinclude bendable sections 25 and 26, respectively. The bendable sectionsmay comprise, for example, a plurality of through-wall slots 27 toenhance flexibility of the tube. Preferably, flexible tubes 13 and 14are made from stainless steel with an etched or laser-cut slot pattern.More preferably, the slot pattern is a sinusoidal repeating pattern ofslots perpendicular to the longitudinal axis of tubes 13 and 14.Alternative flexible patterns will be apparent to those of skill in theart.

[0079] Referring to FIGS. 2A and 2B, tissue grabbing assembly 18comprises pair of jaws 28 a, 28 b arranged to rotate about pivot point29 between an open configuration (FIG. 2A) and a closed configuration(FIG. 2B). Control wire 19 is coupled via pivot point 30 to arms 31 aand 31 b. Arms 31 a and 31 b are in turn pivotally coupled to jaws 28 aand 28 b, respectively, at pivot points 32 a and 32 b. Each of jaws 28 aand 28 b preferably includes sharpened teeth 33 disposed near its distalends to facilitate grasping of the tissue wall of the GI lumen.

[0080] Control wire 19 is coupled to actuator 17 of handle 16 so thattranslation of the wire within flexible tube 13 causes the jaws to openor close. In particular, urging control wire distally (as indicated byarrow A in FIG. 2A) moves pivot point 30 distally, thereby forcing thejaws to open. Urging control wire 19 proximally (as indicated by arrow Bin FIG. 2B) moves pivot point 30 proximally, thereby forcing the jaws toclose together. In alternative embodiments, tissue grabbing assembly 18may comprise a grappling hook or fork, or plurality of needles coupledto the distal end of flexible tube 13.

[0081] Flexible tube 14 is affixed to and immovable within catheter 11,while flexible tube 13 is coupled to catheter 11 only via hinge 20.Accordingly, when control wire 19 is extended in the distal direction,flexible tube 13 is carried in the distal direction. When control wire19 is retracted in the proximal direction, flexible tube remainsstationary until jaws 28 a and 28 b close together, after which furtherretraction of control wire 19 by moving actuator 17 causes flexible tube13 to buckle in bendable region 25, as described hereinafter.

[0082] Referring now to FIGS. 1 and 3A-3E, operation of apparatus 10 isdescribed to create a tissue fold in a tissue wall of a GI lumen. InFIG. 3A, distal region 12 of catheter 11 is positioned within apatient's GI lumen transesophageally, and jaws 28 a and 28 b of tissuegrabbing assembly 18 are opened by moving actuator 17 to the distal-mostposition on handle 16. As depicted in FIG. 3B, actuator 17 may then bemoved proximally until the jaws of tissue grabbing assembly 18 engage aportion of tissue wall W at contact point P1.

[0083] Referring to FIG. 3C, after the tissue wall has been engaged atcontact point P1, flexible tube 13 is urged proximally within catheter11 by further proximal retraction of control wire 19 to stretch tissuewall W and create tissue fold F. During this movement of flexible tube13, link 21 of hinge assembly 20 causes tissue grabbing assembly 18 tomove from a position distal to distal end 24 of flexible tube 14, to aposition proximal of distal end 24 of flexible tube 14. Bendablesections 25 and 26 of flexible tubes 13 and 14, respectively,accommodate any lateral motion caused by operation of hinge assembly 20.Advantageously, formation of fold F facilitates the penetration of thetissue wall by a needle and subsequent delivery of an anchor assembly,as described hereinafter.

[0084] Referring to FIG. 3D, additional proximal movement of actuator 17causes flexible tubes 13 and 14 to buckle at bendable sections 25 and26. Hinge assembly 20 transmits force applied to flexible tube 13 viacontrol wire 19 and actuator 17 to the distal tip 24. Preferably,flexible tube 14 is configured so that distal tip 24 contacts, and issubstantially perpendicular, to tissue fold F at contact point P2. Asillustrated in FIG. 3E, once tissue fold F is stretched across distaltip 24 of flexible tube 14, sharpened needle or obturator 34 may beextended from distal tip 24 of flexible tube 14 to pierce all fourlayers of the tissue wall W. Sharpened needle or obturator 34 isinserted via inlet 35 to flexible tube 14 on handle 16 (see FIG. 1A).

[0085] As discussed above, the GI lumen comprises an inner mucosallayer, connective tissue, the muscularis layer and the serosa layer. Toobtain a durable purchase, e.g., in performing a stomach reductionprocedure, the staples or anchors used to achieve reduction of the GIlumen must engage at least the muscularis tissue layer, and morepreferably, the serosa layer as well. Advantageously, stretching oftissue fold F across distal tip 24 permits an anchor to be ejectedthrough both the muscularis and serosa layers, thus enabling durablegastrointestinal tissue approximation.

[0086] As depicted in FIG. 3E, after tissue fold F is stretched acrossdistal tip 24 of flexible tube 14 to form contact point P2 with tissuewall W, needle 34 may be extended from distal tip 24 and through tissuefold F. Because needle 34 penetrates the tissue wall twice, it exitswithin the gastrointestinal lumen, thus reducing the potential forinjury to surrounding organs. Once the needle has penetrated tissue foldF, an anchor assembly is ejected through distal tip 24 as describedhereinbelow.

[0087] With respect to FIGS. 4A-4C, a first embodiment of an anchorassembly suitable for use with the apparatus of the present invention isdescribed. Anchor assembly 36 comprises T-anchor assembly having distalrod 38 a and proximal rod 38 b connected by suture 39. The preciseshape, size and materials of the anchors may vary for individualapplications. In addition, the suture material also may vary forindividual applications. By way of example, the suture material mayconsist of monofilament wire, multifilament wire or any otherconventional suture material. Alternatively, suture 39 may compriseelastic material, e.g. a rubber band, to facilitate adjustment of thedistance between the proximal and distal rods. Suture 39 extends througha pair of through-holes 40 in each rod, thereby forming a loop.Alternatively, suture 39 may be attached to the rods via an eyelet orusing a suitable adhesive. Preferably, through-holes 40 are located nearthe center of the rods 38 a and 38 b.

[0088] Referring to FIG. 4B, rods 38 a and 38 b may be delivered throughneedle 34 (see FIG. 3E) using push rod 42. Push rod 42 is adapted tofreely translate through flexible tube 14 and needle 34. Push rod 42 ispreferably flexible, so that it may slide through bendable section 26 offlexible tube 14. In addition, push rod 42 may include notch 43 near itsdistal end to facilitate grasping and tensioning suture 39 after anchordelivery.

[0089] During anchor delivery, the longitudinal axis of distal rod 38 ais substantially parallel to the longitudinal axis of needle 34.However, once distal rod 38 a is ejected from needle 34, suture tensioninduces the rod to rotate approximately 90 degrees about itslongitudinal axis, so that its longitudinal axis is substantiallyperpendicular to the longitudinal axis of needle 35. This rotation ofdistal rod 38 a prevents it from being pulled back through tissue wallW.

[0090] Referring to FIG. 4C, once rod 38 a is ejected on the distal sideof fold F, needle 35 is retracted and push rod 42 is used to eject rod38 b on the proximal side of tissue fold F. Like distal rod 38 a,tension in the suture causes proximal rod 38 b to rotate about 90degrees once it is ejected from the needle. Notch 43 in push rod 42 thenmay be employed to tighten suture 39 by any of a variety of mechanisms.Alternatively, suture 39 may comprise an elastic material thatdynamically tightens the rods against tissue fold F.

[0091] Referring now to FIG. 5A, according to other embodiments, theanchor assembly comprises a T-anchor assembly suitable to be disposedover obturator 50. More particularly, distal rod 38 a includesthrough-hole 51 dimensioned for the passage of obturator tip 52, andobturator 50 is translatably inserted through flexible tube 14 via inlet35 of handle 16 (see FIG. 1A). Proximal rod 38 b may be a solid rod thatdoes not include a through-hole for passage of obturator 50.Alternatively, proximal rod 38 b may include a through-hole for thepassage of the obturator. Preferably, obturator tip 52 is sharpened tofacilitate tissue penetration.

[0092] With respect to FIG. 5B, once rod 38 a is ejected on the distalside of fold F, it rotates into a position substantially parallel totissue wall W and perpendicular to the longitudinal axis of theobturator. Obturator 50 then is retracted and proximal rod 38 b isejected from flexible tube 14. More particularly, when flexible tube 14is retracted from tissue wall W, proximal rod 38 b is pulled throughdistal tip 24. Proximal rod 38 b then rotates substantially 90 degreesas it is ejected from flexible tube 14 so that rod 38 b is urged againsttissue wall W.

[0093] Referring to FIG. 6A, according to further embodiments, anchorassembly 55 comprises a T-anchor assembly similar to the embodimentdepicted in FIG. 4A. However, anchor assembly 55 includes fine wiretether 56 that may be twisted to maintain the tension between rods 38 aand 38 b.

[0094] With respect to FIG. 6B, a method of delivering anchor assembly55 is described. Initially, distal rod 38 a is delivered across bothtissue walls using needle 34. The needle then is retracted to releasedistal rod 38 a so that it engages the tissue wall. Next, needle 34 isretracted to release proximal rod 38 b, so that it too rotates intoengagement with the tissue wall. A proximal portion of the wire tetheris captured by notch 43 of push rod 42 (see FIG. 4B), and the push rodis rotated to cause proximal rod 38 b to clamp down on the tissue fold.Because wire tether 56 is twisted by rotation of push rod 42, itmaintains the desired force on the tissue walls.

[0095] Referring now to FIGS. 7, a unidirectionally adjustable anchorassembly suitable for use with apparatus of the present invention isdescribed. Anchor assembly 60 comprises distal anchor 62 andunidirectionally adjustable proximal anchor 64, which are connected bysuture 39. Distal anchor 62 is translationally fixed with respect tosuture 39. Such fixation may be achieved in a variety of ways. Forexample, as seen in FIG. 7A, distal anchor 62 may comprise a pair ofthrough-holes 63, located near the center of anchor 62 and through whichsuture 39 is threaded and tied off at knot 65.

[0096]FIG. 7B provides alternative techniques for fixing the distalanchor. As seen in FIG. 7B(i), distal anchor 62 may comprise hollow tubeT having opening O. A distal end of suture 39 is passed through openingO and formed into knot K, which is dimensioned such that it cannot passthrough opening O, thereby fixing the distal anchor with respect to thesuture. In order to facilitate formation of knot K, distal anchor 62optionally may comprise distal opening DO, which is dimensioned suchthat knot K may pass therethrough. The distal end of suture 39 may bepassed through distal opening DO, knotted, and then pulled back withinhollow tube T of anchor 62 until it catches at opening O.

[0097] A drawback of the fixation technique described with respect toFIG. 7B(i) is a risk of suture 39 being torn or cut due to rubbingagainst opening O. In FIG. 7B(ii), hollow tube T comprises first end Eto which is connected wire loop L, which may be formed, for example froma nickel-titanium alloy (“Nitinol”). Suture 39 passes through the wireloop before terminating at knot K. Knot K is dimensioned such that itcannot pass back through the wire loop. Wire loop L directs suture 39through opening O, thereby reducing rubbing of the suture against theopening and reducing a risk of tearing or cutting of suture 39.

[0098]FIG. 7B(iii) provides yet another alternative technique for fixingthe distal anchor with respect to the suture. Distal anchor 62 againcomprises hollow tube T having opening O. Rod R is disposed within tubeT, and the ends of the tube may be either closed or crimped to rod R,such that the rod is maintained within the tube. The distal end ofsuture 39 is threaded through opening O, around rod R, and back outopening O. The suture is then knotted at knot K, thereby fixing distalanchor 62 with respect to suture 39.

[0099] In addition to the techniques shown in FIGS. 7A and 7B, suture 39alternatively may be fixed with respect to anchor 62 by other means, forexample, via a knotted eyelet or via a suitable adhesive. Additionaltechniques will be apparent to those of skill in the art. While anchor62 is illustratively shown as a rod- or T-type anchor, any of a varietyof anchors, per se known, may be used as distal anchor 62. Exemplaryanchors are described in co-pending U.S. patent application Ser. No.10/612,170, filed Jul. 1, 2003, which is incorporated herein byreference in its entirety. Additional anchors are described hereinbelowwith respect to FIGS. 17. For the purposes of the present invention,anchors and anchor assemblies should be understood to include clips forsecuring tissue, as well as suture knots and knot replacements.Furthermore, anchor assemblies may comprise multiple components that arenot initially coupled to one another; the components may be broughttogether and/or coupled within a patient at a treatment site.

[0100] Referring again to FIG. 7A, adjustable proximal anchor 64comprises outer cylinder 66 having first end 67 a and second end 67 b,as well as first opening 68 a and second opening 68 b. First and secondopenings 68 are preferably disposed near the center of cylinder 66 andapproximately 180° apart. Anchor 64 further comprises first flexible rod70 a and second flexible rod 70 b, both of which are disposed withinouter cylinder 66 and coupled to first and second ends 67 of cylinder66. Rods 70 may be formed, for example, from Nitinol or from a polymer,and may be separated from one another by small gap G. As with theprevious anchor assemblies, the precise shape, size and materials of theanchors and suture may vary as required for specific applications.

[0101] As best seen in FIG. 7C, suture 39 passes from distal anchor 62through first opening 68 a of proximal anchor 64, around second flexiblerod 70 b, around first flexible rod 70 a, between rods 70 a and 70 b,and out through second opening 68 b. This suture winding provides aunidirectional adjustment capability that allows a length L of suture 39disposed between distal anchor 62 and proximal anchor 64 to beshortened. However, the suture winding precludes an increase in lengthL. FIGS. 8 illustrate the mechanism of this unidirectional adjustmentcapability in greater detail. Optionally, suture 39 may be tied offproximal of anchor 64 at knot 69, thereby forming a proximal loop ofsuture to facilitate deployment and/or adjustment of anchor assembly 60.

[0102] In FIG. 8A, a proximally-directed force F₁ is applied to suture39 proximal of adjustable anchor 64, while anchor 64 is held stationaryor is advanced distally. A portion of force F₁ is transferred throughsuture 39 to second flexible rod 70 b, which causes rod 70 b to bow,thereby increasing gap G and allowing suture 39 to freely pass betweenrods 70 a and 70 b and through proximal anchor 64, facilitatingunidirectional adjustment. When anchor 64 is held stationary whilesuture 39 is retracted proximally, distal anchor 62 retracts proximallytowards anchor 64. Alternatively, when anchor 64 is advanced distallywhile suture 39 is retracted proximally, distal anchor 62 either remainsstationary or retracts proximally towards proximal anchor 64, dependingupon a degree of distal advancement of proximal anchor 64. Regardless,length L of suture 39 disposed between anchors 62 and 64 is decreased,thereby unidirectionally adjusting a distance between the anchors.

[0103] In FIG. 8B, a distally-directed force F₂ is applied to suture 39distal of adjustable anchor 64. Force F₂ may be applied, for example, bytissue compressed between anchors 62 and 64. Compressed tissue storesenergy in a manner similar to a compression spring and seeks to pushanchors 62 and 64 apart after unidirectional tightening. Force F₂ causesthe loop of suture 39 around first and second rods 70 to tighten,thereby bowing both rods inward and closing gap G such that suture 39 isfriction locked between first and second flexible rods 70. In thismanner, the length L of suture between anchors 62 and 64 may beselectively decreased but cannot be increased.

[0104] As will be apparent to those of skill in the art, the magnitudeof force required to unidirectionally adjust length L may be altered ina variety of ways. For example, a length, flexibility or diameter ofrods 70 may be altered. Likewise, the elasticity or diameter of suture39 may be altered. Initial gap G may be increased or decreased.Furtherstill, the materials used to form rods 70 and suture 39 may bechanged to alter material properties, such as coefficients of friction,and/or rods 70 or suture 39 may comprise a lubricious coating.Additional methods for varying the magnitude of force, a few of whichare described hereinbelow with respect to FIGS. 9, will be apparent inview of this disclosure and are included in the present invention.

[0105] Referring now to FIGS. 9, alternative anchors 64 are described.In FIG. 9A, flexible rods 70 of proximal adjustable anchor 64′ arerotated with respect to openings 68 (or vice versa). When utilizing thesuture winding described in FIGS. 7 and 8, rotation of rods 70 up to180° clockwise progressively increases friction when force is applied toanchors 62 and 64. The magnitude of the friction lock is increased whenforce is applied in the manner described with respect to FIG. 8B.However, friction is also increased when unidirectionally adjusting thelength of suture between the proximal and distal anchors by applyingforce in the manner described with respect to FIG. 8A. Rotation of rods70 more than about 180° clockwise would cause anchor 64′ to frictionlock regardless of which direction force were applied to suture 39,thereby negating the unidirectional adjustment capability.Counterclockwise rotation of rods 70 with respect to openings 68 wouldinitially reduce friction during force application to suture 39 ineither direction. It is expected that counterclockwise rotation inexcess of about 90° would eliminate the friction lock described in FIG.8B and allow bidirectional adjustment. Continued counterclockwiserotation beyond about 450° would reverse the directions of friction lockand unidirectional adjustment, while counterclockwise rotation beyondabout 720° would result in friction lock regardless of which directionforce were applied to suture 39.

[0106] As discussed previously, openings 68 of cylinder 66 of anchor 64are preferably disposed approximately 180° apart from one another.However, in order to increase the friction lock force withoutsignificantly increasing friction during unidirectional adjustment,first opening 68 a may be rotated counterclockwise with respect tosecond opening 68 b (or vice versa), as seen with anchor 64″ of FIG. 9B.In this manner, first opening 68 a is no longer in line with rods 70,while second opening 68 b remains in line with rods 70. When force F₁ isapplied to anchor 64″, second flexible rod 70 b is able to bow outwardand increase gap G, thereby facilitating unidirectional adjustment.Likewise, when force F₂ is applied to the anchor, gap G is closed moretightly upon suture 39, thereby increasing the friction lock force. Iffirst opening 68 a alternatively were rotated clockwise with respect tothe second opening, it is expected that the friction lock force would bedecreased.

[0107] In FIG. 9C, proximal adjustable anchor 64′″ comprises analternative suture winding. Suture 39 passes from distal anchor 62through first opening 68 a of anchor 64′″, around second flexible rod 70b, around first flexible rod 70 a, back around second flexible rod 70 b,between rods 70 a and 70 b, and out through second opening 68 b. As withthe suture winding described with respect to anchor 64 of FIGS. 7 and 8,the suture winding illustrated in FIG. 9C provides a unidirectionaladjustment capability that allows a length L of suture 39 disposedbetween distal anchor 62 and proximal anchor 64′″ to be shortened.However, this suture winding precludes an increase in length L.Additional unidirectionally adjustable suture windings will be apparentto those of skill in the art.

[0108] With reference to FIGS. 10, an alternative unidirectionallyadjustable anchor comprising three rods is described. Anchor assembly 80comprises distal anchor 62 and proximal anchor 82. Unidirectionallyadjustable proximal anchor 82 comprises outer cylinder 84 having firstend 85 a and second end 85 b (not shown), as well as first opening 86 aand second opening 86 b. First and second openings 86 are preferablydisposed near the center of cylinder 84 and approximately 180° apart.Anchor 82 further comprises first flexible rod 88 a, second flexible rod88 b and third flexible rod 88 c, all of which are disposed within outercylinder 66 and coupled to first and second ends 85 of cylinder 64. Rods88 are separated from one another by gaps G₁ and G₂.

[0109] Suture 39 passes from distal anchor 62 through first opening 86 aof proximal anchor 82, around first rod 88 a, between first rod 88 a andsecond rod 88 b, between second rod 88 b and third rod 88 c, aroundthird rod 88 c, back to and around first rod 88 a, and out throughsecond opening 86 b. As seen in FIG. 10A, when force F₁ is applied tosuture 39, gaps G_(1 and G) ₂ remain open, thereby facilitatingunidirectional adjustment/shortening of length L of suture 39 disposedbetween distal anchor 62 and proximal anchor 82. As seen in FIG. 10B,when force F₂ is applied to suture 39, gaps G₁ and G₂ close down uponsuture 39, thereby forming a friction lock that precludes an increase inlength L of suture 39.

[0110] Referring now to FIGS. 11, an alternative three rod anchorassembly is described. The unidirectionally adjustable anchors describedhereinabove with respect to FIGS. 7-10 all comprise rods disposed withina cylinder having openings for passage of a suture. The openings act tocenter the suture with respect to the rods and can be used to altermagnitudes of force applied during adjustment and friction locking, asdiscussed previously. However, such openings present a risk of tearingor cutting the suture as the suture slides through the openings.

[0111] As seen in FIGS. 11, anchor assembly 90 comprises distal anchor62 and proximal anchor 92. Unidirectionally adjustable proximal anchor92 comprises first flexible rod 94 a and second flexible rod 94 b, aswell as rigid rod 96, which is preferably larger in diameter than firstand second rods 94. Flexible rods 94 are preferably fabricated fromNitinol or a polymer, while rigid rod 96 is preferably fabricated fromstainless steel or a polymer. Alternative materials will be apparent tothose of skill in the art.

[0112] Anchor 92 further comprises first outer cylinder 98 a and secondouter cylinder 98 b, which are crimped to the ends of first and secondrods 94, and rigid rod 96. As an alternative to crimping, first andsecond cylinders 98 may each comprise an end cap (not shown) to whichthe rods are coupled. First and second cylinders 94 do not span acentral portion of anchor 92. Flexible rods 94 are separated from oneanother by gap G₁, while rods 94 are separated from rigid rod 96 by gapG₂.

[0113] Anchor 92 comprises three rods, but, unlike anchor 82 of FIGS.10, suture 39 is only wrapped around two of them to achieveunidirectional adjustment. As best seen in FIGS. 11B and 11C, theillustrative suture winding of anchor assembly 90 is similar to thatdescribed previously with respect to anchor assembly 60 of FIGS. 7 and8. The break between first and second cylinders 98 acts to center suture39 with respect to the rods, as seen in FIG. 11A, while rigid rod 96acts to stiffen and reduce rotation of anchor 92 as it directs suture 39about flexible rods 94.

[0114] Suture 39 passes from distal anchor 62 to proximal anchor 92,between rigid rod 96 and flexible rods 94, around second flexible rod 94b, around first flexible rod 94 a, between rigid rod 96 and firstflexible rod 94 a, between flexible rods 94 a and 94 b, and out. As seenin FIG. 11A, when force F₁ is applied to suture 39, flexible rods 94 areforced apart and gap G₁ widens while gap G₂ remains substantiallyconstant, thereby allowing unidirectional adjustment of length L ofsuture 39 disposed between distal anchor 62 and proximal anchor 92. Asseen in FIG. 11B, when force F₂ is applied to suture 39, gap G₁ closesdown upon suture 39, thereby forming a friction lock that precludes anincrease in length L of suture 39. Gap G₂ again remains substantiallyconstant.

[0115] With reference to FIG. 12, an alternative unidirectionallyadjustable anchor assembly comprising pivots is described. Anchorassembly 100 comprises distal anchor 62 and proximal anchor 102.Unidirectionally adjustable proximal anchor 102 comprises outer cylinder103 having first end 104 a and second end 104 b (not shown), as well asfirst opening 105 a and second opening 105 b. First and second openings105 are preferably disposed near the center of cylinder 103 andapproximately 180° apart. Anchor 102 further comprises first rod orpaddle 106 a and second rod or paddle 106 b, both of which are disposedwithin outer cylinder 103 and coupled to the first and second ends ofcylinder 103 by pins 107, which pass through pivot holes 108. In thismanner, first and second paddles 106 are able to rotate about pivotholes 108. Paddles 106 may be formed, for example, from stainless steelor a polymer, and are separated from one another by gap G. As with theprevious anchor assemblies, the precise shape, size and materials of theanchors, as well as suture 39, may vary as required for specificapplications.

[0116] Suture 39 illustratively passes from distal anchor 62 throughfirst opening 105 a of proximal anchor 102, around second paddle 106 b,around first paddle 106 a, between paddles 106 a and 106 b, and outthrough second opening 105 b. The placement of pivot holes 108 ensuresthat application of force F₁, as described hereinabove, causes paddles106 to rotate apart from one another and expand gap G, thereby enablingunidirectional adjustment. Likewise, application of previously discussedforce F₂ causes paddles 106 to rotate together, thereby closing gap Gand pinching suture 39 between the paddles in a friction lock. Anincrease in the magnitude of force F₂ serves to rotate paddles 106together more tightly, thereby increasing the magnitude of the frictionlock acting upon suture 39 between the paddles. In this manner,unidirectional adjustment is achieved.

[0117] Referring now to FIG. 13, an alternative unidirectionallyadjustable anchor assembly comprising spring material is described.Anchor assembly 110 comprises distal anchor 62 and proximal anchor 112.Unidirectionally adjustable proximal anchor 112 comprises outer cylinder113 having first end 114 a and second end 114 b (not shown), as well asfirst opening 115 aand second opening 115 b. First and second openings115 are preferably disposed near the center of cylinder 113 andapproximately 180° apart. Anchor 112 further comprises first rod 116 aand second rod 116 b that are separated by gap G, as well as springmaterial 118, all of which are disposed within outer cylinder 113.Spring material 118 abuts rods 116, which preferably are substantiallythe same length as cylinder 113, and may either move freely withincylinder 113 or may be coupled to the ends (not shown) of cylinder 113.Spring material 118 may also move freely within cylinder 113 or may becoupled to the cylinder, and comprises lumen 119 having a diameter thatis preferably equal to or less than the diameter of suture 39. Springmaterial 118 may comprise, for example, a compressible biocompatiblefoam, which acts as a compression spring.

[0118] Suture 39 passes from distal anchor 62 to proximal anchor 112through first opening 115 a of cylinder 113, between rods 116, throughlumen 119 of spring material 118, and out through second opening 115 b.Lumen 119 snugly contacts suture 39 such that application of force F₁causes friction between the suture and the spring material to compressthe spring material against the wall of cylinder 114, thereby reducing astress applied to rods 116 by spring material 118 and increasing gap Gsuch that unidirectional adjustment of length L of suture 39 disposedbetween distal anchor 62 and proximal anchor 102 may proceed.Application of force F₂ stretches spring material 118 against rods 116,thereby increasing the stress applied to the rods by the spring materialand closing gap G such that suture 39 is friction locked between rods116.

[0119] With reference to FIGS. 14, alternative unidirectionallyadjustable anchor assemblies comprising one-way valves are described. InFIG. 14A, anchor assembly 120 comprises distal anchor 62 and proximalanchor 122. Unidirectionally adjustable proximal anchor 122 comprisesouter cylinder 124 having first and second ends 125 a and 125 b, as wellas first opening 126 a and second opening 126 b. First and secondopenings 126 are preferably disposed near the center of cylinder 124 andapproximately 180° apart. Anchor 122 further comprises first inclinedplane 128 a and second inclined plane 128 b, which are forced intoapposition by compression springs 129 a and 129 b, thereby formingone-way valve V at the junction of the two inclined planes. Inclinedplanes 128 and springs 129 are disposed within outer cylinder 124;springs 129 abut ends 125 of cylinder 124, as well as the ends of theinclined planes. Suture 39′ comprises a plurality of knots or beads Badapted to actuate one-way valve V.

[0120] Suture 39′ passes from distal anchor 62 to proximal anchor 122through first opening 126 a of cylinder 124, between inclined planes128, through one-way valve V, and out through second opening 126 b.Application of force F₁ to suture 39′ causes a bead B to contactinclined planes 128 and gradually coax them apart by compressing springs129, thereby opening valve V and allowing the bead to pass through thevalve. Once the bead has passed through valve V, springs 129 forceinclined planes 128 back into apposition, thereby closing the valve.Continued application of force F₁ allows multiple beads to pass throughthe valve, which facilitates unidirectional adjustment of suture lengthL disposed between distal anchor 62 and proximal anchor 122. Applicationof force F₂ causes a bead B of suture 39′ to impinge upon the proximalsides of inclined planes 128. However, force transferred to the planesby the bead is perpendicular to the direction required to compresssprings 129 and urge planes 128 apart. As such, the bead B impingingupon the proximal sides of planes 128 is not able to open one-way valveV and pass back through the valve in a distal direction, therebyensuring only unidirectional adjustment, i.e. shortening, of the lengthL of suture disposed between the proximal and distal anchors.

[0121] In FIG. 14B, an alternative unidirectionally adjustable anchorhaving a one-way valve is described. Anchor assembly 130 comprisesdistal anchor 62 and proximal anchor 132. Unidirectionally adjustableproximal anchor 132 comprises lumen 134 having cantilevered inclinedplane 136 disposed therein, which forms one-way valve V. ‘Zip-tie’fastener 138, having a plurality of inclined planes 139, connectsproximal anchor 132 and distal anchor 62. The plurality of inclinedplanes 139 are disposed about 180° out of phase with inclined plane 136of anchor 132.

[0122] Fastener 138 passes from distal anchor 62 to proximal anchor 132,through lumen 134 and past inclined plane 136. Inclined planes 139 offastener 138 mesh with inclined plane 136 and bend or cantilever plane136, such that planes 139 of fastener 138 may proximally pass one-wayvalve V when force F₁ is applied to the fastener, thereby enablingunidirectional adjustment of length L of fastener 138 disposed betweenthe proximal and distal anchors. Conversely, when force F₂ is applied tothe fastener, the proximal side of inclined plane 136 of anchor 132abuts the distal side of an inclined plane 139 of fastener 138, and thefastener cannot be drawn distally through proximal anchor 132, nor canthe length L of fastener disposed between the anchors be increasedsignificantly.

[0123] Referring now to FIGS. 15, alternative unidirectionallyadjustable anchor assemblies comprising a slipknot are described. InFIG. 15A, anchor assembly 140 comprises distal anchor 142 and proximalanchor 144. Through-holes 143 a and 143 b extend through distal anchor142, while through-holes 145 a and 145 b extend through proximal anchor145. Preferably, through-holes 143 and 145 are located near the centerof anchors 142 and 144, respectively.

[0124] The distal end of suture 39 passes through through-hole 145 a ofproximal anchor 144 to distal anchor 142, where it passes throughthrough-hole 143 a and back through through-hole 143 b. It then extendsfrom distal anchor 142 back to proximal anchor 144, where it passesthrough through-hole 145 b of the proximal anchor. The distal end ofsuture 39 is tied off at unidirectional slipknot S, which is locatedproximal of anchor 144. FIG. 15B provides a detail view illustratingformation of slipknot S.

[0125] As will be apparent to those of skill in the art, application offorce F₁ causes suture 39 to slide through through-holes 143 and 145,and decrease the length L of suture 39 disposed between anchors 142 and144. Suture 39 may readily pass through slipknot S in a proximaldirection, thereby facilitating unidirectional adjustment of length L.However, application of force F₂ tightens slipknot S and prohibitspassage of suture 39 through the slipknot in a distal direction, therebyprecluding an increase in length L.

[0126]FIG. 15C illustrates an alternative embodiment of anchor assembly140 wherein the slipknot is disposed within the proximal anchor. Anchorassembly 140′ comprises distal anchor 142 and proximal anchor 144′.Proximal anchor 144′ comprises hollow cylinder or tube 146 having distalopenings 147 a and 147 b, and proximal opening 148.

[0127] The distal end of suture 39 passes through proximal opening 148into the interior of tube 146. It then passes through distal opening 147a of proximal anchor 144′ to distal anchor 142, where it passes throughthrough-hole 143 a and back through through-hole 143 b. Next, suture 39extends from distal anchor 142 back to proximal anchor 144′, where itpasses through distal opening 147 b into the interior of tube 146 of theproximal anchor. The distal end of suture 39 is tied off atunidirectional slipknot S, which is disposed within tube 146 of anchor144′. Anchor assembly 140′ may be unidirectionally adjusted in a mannersimilar to that described hereinabove with respect to anchor assembly140 of FIG. 15A.

[0128]FIGS. 7-15 have illustrated anchor assemblies comprising variousmechanisms for achieving unidirectional adjustment of the distancebetween the proximal and distal anchors. These mechanisms have beenprovided solely for the sake of illustration and should in no way beconstrued as limiting. Additional mechanisms for achievingunidirectional adjustment will be apparent to those of skill in the artin view of this disclosure and are included in the present invention.Furthermore, a majority of the anchor assemblies of FIGS. 7-15 have beendescribed with the distal anchor being fixed relative to the suture, andthe proximal anchor being adjustable. However, it should be understoodthat the distal anchor may alternatively be adjustable and the proximalanchor may be fixed, and/or both anchors may be unidirectionallyadjustable, as with anchor assembly 140 of FIGS. 15.

[0129] With reference now to FIGS. 16, a bi-directionally adjustableanchor assembly comprising a locking mechanism is described. Anchorassembly 150 comprises distal anchor 62 and proximal anchor 152. As seenin FIG. 16A, bi-directionally adjustable proximal anchor 152 comprisesouter cylinder 153 having first end 154 a and second end 154 b, as wellas first opening 155 a and second opening 155 b. First and secondopenings 155 are preferably disposed near the center of cylinder 153 andapproximately 90° apart. Proximal anchor 152 further comprises tensionspring 158 disposed within outer cylinder 153.

[0130] As seen in FIG. 16B, suture 39 passes from distal anchor 62 toproximal anchor 152 through first opening 155 a, around spring 158, andout through second opening 155 b. Suture 39 moves freely about tensionspring 158 in either direction during application of force F₁ or forceF₂, thereby facilitating bi-directional adjustment of suture length Ldisposed between the proximal and distal anchors. However, as seen inFIG. 16C, simultaneous application of forces F₁ and F₂ with sufficientmagnitude causes suture 39 to force threads T of spring 158 apart, suchthat suture 39 is trapped between threads T and locked in position,thereby precluding further adjustment of suture length L.

[0131] The magnitude of forces required to actuate the locking mechanismof proximal anchor 152 and lock suture 39 within threads T of spring 158may be specified/altered in a variety of ways. For example, the angularspacing of openings 155 about outer cylinder 153 may be altered, thespring constant of spring 158 may be specified, and/or spring 158 orsuture 39 may comprise a lubricious coating. Additional techniques willbe apparent to those of skill in the art. It is expected thatsimultaneous application of forces F₁ and F₂ will be encountered whenanchor assembly 150 has been deployed across a tissue fold and suturelength L has been adjusted such that the tissue fold is compressed. Amedical practitioner would then apply force F₁, while the compressedtissue fold would apply force F₂.

[0132] Although the anchor assemblies of FIGS. 10-16 have illustrativelybeen described without knots or loops of suture or fastener disposedproximal of the proximal anchor (as seen, for example, with knot 69 onsuture 39 of anchor assembly 60 in FIGS. 7 and 8) it should beunderstood that such loops or knots optionally may be provided in orderto facilitate deployment and/or adjustment of the anchor assemblies.Additionally, the previously described anchor assemblies illustrativelycomprise distal rod- or T-type anchors. However, it should be understoodthat distal T-anchors have only been provided for the sake ofillustration. The distal anchors (as well as the proximal anchors) maycomprise any of a variety of anchors, per se known, including, forexample, surgical or endoluminal clips, clips for securing tissue andsuture knots or knot replacements. Exemplary anchors are described inco-pending U.S. patent application Ser. No. 10/612,170, filed Jul. 1,2003, which is incorporated herein by reference in its entirety.Furthermore, anchor assemblies may comprise multiple components that arenot initially coupled to one another; the components may be broughttogether and/or coupled within a patient at a treatment site. Additionalanchors are described hereinbelow with respect to FIGS. 17.

[0133] Referring to FIG. 17A, articulating anchor 160 includessemi-cylindrical base 161, rod 162 and suture 39. Rod 162 rotates aboutpivot point 163 (as indicated by arrow 164) between an expanded position(shown in FIG. 7A) and a reduced profile position, wherein rod 162pivots within the semi-cylindrical base 161. Articulating anchor 160 maybe delivered through a tissue fold using, for example, needle 34described hereinabove with respect to FIG. 3E. Preferably, articulatinganchor 160 is biased in the expanded position so that it automaticallyexpands once it is ejected from the needle.

[0134] With respect to FIGS. 17B and 17C the anchors of the presentinvention also may comprise one or more oblong bodies connected by atleast one suture. In FIG. 17B, anchor 165 comprises elliptical ring 166having sutures 39 attached at substantially opposite sides of the ring.In FIG. 17C, anchor 168 comprises angle bracket 169 having a pair ofthrough-holes 170 for suture 39. In FIG. 17D, anchor 171 comprisesoblong bead 172 having a pair of through-holes 173 for suture 39. Allthree anchors 165, 168 and 171 (as well as the T-anchors describedpreviously) have a first dimension (e.g., width) that is substantiallylarger than a second dimension (e.g., height). This dimensionaldifference necessitates that anchors 165, 168 and 171 be inserted withina needle (e.g., needle 34 of FIG. 3E) in a particular orientation. Oncethe anchor is ejected through a tissue wall, tension on suture 39 forcesthe anchor to rotate so that it cannot be pulled back through the tissuewall. As will be understood by those of skill in the art, numerous otheranchors may be employed without departing from the scope of the presentinvention.

[0135] Referring now to FIG. 18A, an alternative embodiment of apparatusfor forming a tissue fold, constructed in accordance with the principlesof the present invention, is described. Apparatus 175 comprisestreadmill assembly 176 disposed at distal tip 174 of flexible tube 177.Flexible tube 177 is configured to be inserted through a patient'smouth, esophagus and into the stomach. Treadmill assembly 176 comprisesconveyor 180 that circles around a pair of hubs 181 a and 181 b. Hubs181 a and 181 b rotate about axles 182 a and 182 b, respectively, andare interconnected by bracket 183. A plurality of barbs or needles 185is disposed at substantially regular intervals around the circumferenceof conveyor 180.

[0136] Flexible tube 177 preferably includes a plurality of through-wallslots 186 to enhance flexibility of the tube, yet maintaintorqueability. Preferably, flexible tube 177 is made from stainlesssteel with an etched or laser-cut slot pattern. Preferably, the slotpattern is a sinusoidal repeating pattern of slots perpendicular to thelongitudinal axis of the tube. Additional and/or alternative patternswill be apparent to those of skill in the art.

[0137] Referring to FIGS. 18 and 19, transmission of motive force totreadmill assembly 176 is described. In particular, drive shaft 202disposed within flexible tube 177 is coupled to a manual knob or motorlocated at the proximal end of the catheter. The distal tip of driveshaft 202 is provided with beveled gear 203 that meshes with beveledgear 204 provided on axle 182 b. Accordingly, rotation of beveled gear203 is transmitted to beveled gear 204, thereby causing axle 182 b torotate. Axle 182 b in turn rotates hub 181 b, actuating conveyor 180.Reversing the rotation of drive shaft 202 reverses the direction ofconveyor 180.

[0138] Referring again to FIGS. 18A-18D, a method of forming agastrointestinal tissue fold F using apparatus 175 is described. In FIG.18A, flexible tube 177 is positioned transesophageally so that treadmillassembly 176 contacts tissue wall W. Preferably, contact should be madeat an angle relative to the tissue wall W. For example, an angle ofapproximately 45 degrees is depicted in FIG. 8A, while many other anglesmay be used without departing from the scope of the present invention.

[0139] When treadmill assembly 176 contacts tissue wall W, needle 185engages the tissue at contact point P1 as the needle moves around distalhub 181 a. As depicted in FIG. 18B, as the needle moves away from distalhub 181 a, tissue wall W is pulled towards proximal end 181 b, therebyforming a small tissue fold F. As the treadmill assembly continues toturn, subsequent needles 185 engage the tissue wall so that it becomessecurely engaged to treadmill assembly 176 along the length of conveyor180.

[0140] As depicted in FIG. 18C, once tissue wall W is securely engagedto treadmill assembly 176, distal end 174 of flexible tube 177 may bearticulated in bendable section 190, thereby moving treadmill assembly176 away from tissue wall W. The articulation of flexible tube 177 maybe accomplished using a control wire and actuator disposed at theproximal end of the catheter, as previously described with respect tothe embodiment of FIGS. 1. By moving the treadmill assembly away fromtissue wall W, additional tissue is pulled proximally and tissue fold Fbecomes elongated.

[0141] In FIG. 18D, tissue fold F is stretched across bendable section190 of flexible tube 177 to create contact point P2. This permits asharpened needle or obturator to be extended through one of slots 186 ofbendable section 190 and across all four layers of the tissue wall W.Advantageously, stretching of tissue fold F across bendable section 190permits an anchor to be ejected through both the muscularis and serosalayers, thus providing a durable foundation for gastrointestinal tissueapproximation. For example, needle 192 may be extended through slot 186in bendable section 190, and through the base of tissue fold F, and ananchor assembly (such as described with respect to any of FIGS. 4-17)may be ejected from needle 192 to secure the fold. Alternatively, anobturator (such as described with respect to FIGS. 5A and 5B) may beused to pierce the tissue fold at contact point P2 and deliver theanchor assembly. Treadmill assembly 176 may be disengaged from tissuewall W by reversing the rotation of proximal hub 181b.

[0142] Referring now to FIG. 20A, a further alternative embodiment ofapparatus for forming a tissue fold in accordance with the principles ofthe present invention is described. Apparatus 200 comprises tissuegrabbing assembly 18′ coupled to the distal end of a flexible tube 177′,such as described with respect to the embodiment of FIGS. 18. Flexibletube 177′ preferably includes a plurality of through-wall slots 186′ toenhance flexibility of the tube, yet maintain torqueability. Inaddition, flexible tube 177′ may be made from stainless steel with anetched or laser-cut slot pattern, such as a sinusoidal repeating patternof slots perpendicular to the longitudinal axis of the tube. Alternativeflexible patterns will be apparent.

[0143] Tissue grabbing assembly 18′ is similar to that described withrespect to the embodiment of FIGS. 1, and comprises a pair of jaws 28a′, 28 b′ arranged to rotate about pivot point 29′ between an openconfiguration and a closed configuration. Each of jaws 28 a′, 28 b′preferably includes sharpened teeth 33′ disposed near its distal end tofacilitate grasping tissue wall W.

[0144] With respect to FIG. 20A, tissue grabbing assembly 18′ ispositioned transesophageally adjacent to tissue wall W and jaws 28 a′,28 b′ are moved to the open position. Tissue grabbing assembly 18′ thenis moved into contact with tissue wall W. As depicted in FIG. 20B,tissue grabbing assembly 18′ is used to grab the tissue wall at a firstcontact point P1. After capturing a portion of tissue wall W within jaws28 a′, 28 b′, flexible tube 177′ is urged proximally to stretch tissuewall W and create tissue fold F.

[0145] Referring to FIG. 20C, once tissue fold F is formed, the distalend of flexible tube 177′ is articulated about bendable section 190′ tomove tissue grabbing assembly 18′ away from tissue wall W. Articulationof flexible tube 177′ may be controlled using an actuator disposed atthe proximal end of the catheter, thus causing tissue fold F to becomeelongated.

[0146] In FIG. 20D, tissue fold F is shown stretched across bendablesection 190′ so that a sharpened needle or obturator may be extendedfrom one of slots 186′ in bendable section 190′ and across all fourlayers of the tissue wall W. Needle 192′ then may be extended from slot186′ in bendable section 190′ through contact point P2 and tissue foldF. An anchor assembly (e.g., as described with respect to any of FIGS.4-17) then may be ejected from needle 192′ to secure the fold.Alternatively, an obturator (e.g., as described with respect to FIGS. 5Aand 5B) may be used to pierce the tissue fold at contact point P2 anddeliver the anchor assembly.

[0147] With reference now to FIGS. 21, an anchor delivery system adaptedfor use with the adjustable anchor assemblies of FIGS. 7-17 isdescribed. In FIGS. 21, the anchor delivery system is illustrativelyshown in use with anchor assembly 60 of FIGS. 7, but this should in noway be construed as limiting. Also, the delivery system of FIGS. 21 maybe used in conjunction with apparatus for forming a tissue fold, such asapparatus 10, 175 and 200 described previously, or alternative apparatusdescribed hereinafter, in order to anchor the tissue fold.Alternatively, the delivery system may be used for any otherapplication, or in conjunction with any other apparatus, requiringdelivery of an anchor assembly.

[0148] In FIG. 21A, a distal region of anchor delivery system 250 isdisposed adjacent tissue fold F in tissue wall W. Anchor delivery system250 comprises flexible delivery tube 252 having lumen 253. Flexibledelivery tube 252 may be configured for insertion through a patient'smouth and esophagus into a gastrointestinal lumen, such as the stomach.Lumen 253 of delivery tube 252 preferably has a diameter of less thanabout 5 mm, and even more preferably has a diameter of about 2-3 mm.Flexible delivery tube 252 preferably includes a plurality ofthrough-wall slots 254 to enhance flexibility of the tube, yet maintaintorqueability. Slots 254 may form bendable section 255. Preferably,flexible delivery tube 252 is made from stainless steel with an etchedor laser-cut slot pattern. The slot pattern is preferably a sinusoidalrepeating pattern of slots perpendicular to the longitudinal axis of thetube. Additional and/or alternative patterns will be apparent.

[0149] Anchor delivery system 250 further comprises delivery needle 260.Needle 260 preferably has a length of less than 2 cm, and even morepreferably has a length of about 1.5 cm. Needle 260 preferably comprisessharpened distal tip 262, lumen 264, slot 266 extending proximally fromdistal tip 262, and proximal eyelet 268.

[0150] Lumen 264 of needle 260 is dimensioned such that a distal anchormay be disposed therein. As discussed previously, anchor delivery system250 is illustratively described in conjunction with anchor assembly 60of FIGS. 7. In FIG. 21A, distal anchor 62 is disposed within lumen 264of needle 260. Suture 39 passes through slot 266 of the needle as thesuture extends from distal anchor 62 to proximal anchor 64. Needle 260preferably is disposed within lumen 253 of flexible delivery tube 252distal of bendable section 255, while proximal anchor 64 preferably isdisposed within delivery tube 252 proximal of bendable section 255.

[0151] In this arrangement, distal anchor 62 may be deployed throughneedle 260 while the bendable section is actuated or bent, e.g., whenanchor delivery system 250 is used in conjunction with previouslydescribed plication apparatus. Proximal anchor 64 subsequently may beadvanced through bendable section 255 after the bendable section hasonce again been straightened. The distance, or length, of suture 39extending between distal anchor 62, which is disposed distal of thebendable section, and proximal anchor 64, which is disposed proximal ofthe bendable section, is preferably greater than or equal to about 2 cm,and is even more preferably greater than or equal to about 4 cm.

[0152] Needle 260 is proximally coupled to needle pushrod 270, whichfacilitates translation of the needle beyond a distal end of flexibledelivery tube 252. Needle pushrod 270 extends to a control actuatordisposed at a proximal end of anchor delivery system 250 (not shown).Pushrod 270 optionally may be spring-loaded (not shown), for example, tofacilitate puncture of tissue wall W and passage of needle 260 throughtissue fold F.

[0153] Anchor delivery system 250 further comprises anchor pushrod 280,which is removably disposed through eyelet 268 of needle 260, and isconfigured to eject distal anchor 62 from lumen 264 of needle 260. Aswith needle pushrod 270, anchor pushrod 280 extends to a controlactuator disposed at a proximal end of anchor delivery system 250 (notshown). The actuators controlling pushrods 270 and 280 are preferably atleast partially coupled so that relative motion between the two pushrodscan be limited and/or eliminated, as needed. Pushrod 280 passes throughthe proximal loop of suture formed by knot 69 on suture 39, such thatthe suture loop is threaded between needle pushrod 270 and anchorpushrod 280. This facilitates unidirectional adjustment of the length ofsuture disposed between distal anchor 62 and proximal anchor 64, asdescribed hereinbelow.

[0154] In FIG. 21B, pushrods 270 and 280 are simultaneously distallyadvanced with sufficient force, e.g., via spring-loading, such thatsharpened distal tip 262 of needle 260 pierces tissue wall W and isadvanced across fold F. Bendable section 255 of flexible delivery tube252 optionally may be bent during advancement of the needle, asdescribed previously with respect to the plication apparatus (see FIG.3E). Anchor pushrod 280 is then advanced distally with respect to needlepushrod 270 and needle 260, such that it abuts distal anchor 62 andejects the anchor from lumen 264 of needle 260 on the distal side oftissue fold F, as seen in FIG. 21C. Suture 39 likewise is ejected fromslot 266 and disposed across fold F.

[0155] During delivery, the longitudinal axis of distal anchor 62 issubstantially parallel to the longitudinal axis of needle 260. However,once anchor 62 has been ejected from needle 260, suture tension inducesthe anchor to rotate approximately 90° about its longitudinal axis, sothat its longitudinal axis is substantially perpendicular to thelongitudinal axis of needle 260. This rotation of distal anchor 62prevents it from being pulled back through tissue wall W. One or bothends of anchor 62 may be flared outward (not shown) to facilitate suchrotation upon contact with the tissue wall.

[0156] In FIG. 21D, anchor pushrod 280 is retracted proximally withinlumen 264 of needle 260, the needle is retracted within flexiblydelivery tube 252 via pushrod 270, and then delivery system 250 isretracted proximally across tissue fold F. Distal anchor 62 is disposedon the distal side of the tissue fold, suture 39 extends through thefold, and proximal anchor 64 is disposed on the proximal side of thefold within delivery tube 252. If bendable section 255 were flexedduring deployment of distal anchor 62 (see FIG. 3E), it is straightenedto facilitate delivery of the proximal anchor.

[0157] Delivery tube 252 is then retracted proximally with respect topushrods 270 and 280, causing needle 260 to exit lumen 253 of thedelivery tube on the proximal side of tissue fold F, thereby providingspace for proximal anchor 64 to exit the lumen. Next, delivery tube 252or the full delivery system 250 is retracted, such that proximal anchor64 is ejected from delivery tube lumen 253, as seen in FIG. 21E.Delivery tube 252 is then re-advanced and/or pushrods 270 and 280 aresimultaneously retracted, such that needle 260 is repositioned withinlumen 253 of the delivery tube.

[0158] Flexible delivery tube 252 is advanced with respect to needle260, such that it pushes proximal anchor 64 distally. The proximalsuture loop formed by knot 69 on suture 39 catches against the proximalend of needle 260 and anchor pushrod 280, which pulls distal anchor 62taut against tissue fold F, as seen in FIG. 21F. Continued advancementof delivery tube 252 unidirectionally adjusts, i.e. shortens, length Lof suture 39 disposed between distal anchor 62 and proximal anchor 64,while forcing proximal anchor 64 against the tissue fold and firmlyanchoring the fold between the proximal and distal anchors.

[0159] Once length L has been adjusted such that anchor assembly 60firmly anchors tissue fold F in position, anchor pushrod 280 may beretracted proximally with respect to needle pushrod 270 and needle 260,such that the distal end of anchor pushrod 280 is proximally retractedthrough eyelet 268 and out of needle 260. As seen in FIG. 21G, thesuture loop formed by knot 69 on suture 39 slips off the distal end ofanchor pushrod 280, removing anchor assembly 60 from anchor deliverysystem 250. Anchor delivery system 250 may then be removed from thepatient. Alternatively, needle 260, needle pushrod 270 and anchorpushrod 280 may be proximally retracted and removed from lumen 253 ofanchor delivery tube 252. An additional anchor assembly 60 may then bereloaded within needle 260 and delivery tube 252 from a proximal end ofthe delivery tube, while a distal end of the delivery tube remainswithin the patient. The additional anchor assembly may, for example, beplaced across an additional tissue fold.

[0160] Delivery system 250 optionally may comprise cutting apparatus(not shown) for removing the portion of suture extending proximally ofproximal anchor 64 post-adjustment. Alternatively, secondary apparatusmay be provided to remove such proximal length of suture. As yet anotheralternative, the unneeded length of suture may be left within thepatient post-procedure.

[0161] In order to decrease the number of steps required to deliver andadjust anchor assembly 60, once distal anchor 62 has been deployed, asin FIG. 21C, the entire anchor delivery system 250 may be retractedproximally, such that needle 260 is retracted across tissue fold F whilestill disposed outside of delivery tube lumen 253. This is in contrastto the method described with respect to FIG. 21D, wherein the needle isdisposed within the delivery tube prior to retraction across the tissuefold. Continued proximal retraction of anchor delivery system 250 ordelivery tube 252 deploys proximal anchor 64 from delivery tube lumen253. Anchor assembly 60 then may be unidirectionally adjusted, asdescribed previously.

[0162] Anchor delivery system 250 advantageously provides a medicalpractitioner with significant control during all steps of anchorassembly deployment. Such control affords the medical practitioner ampleopportunity to abort deployment of the anchor assembly. Upon passage ofneedle 260 across tissue fold F, as seen in FIG. 21B, the medicalpractitioner may decide to retract the needle across the fold and notlaunch the distal anchor. Alternatively, after deployment of the distalanchor 62, as seen in FIG. 21D, the medical practitioner may decide notto deploy the proximal anchor and may sever the suture connecting theproximal and distal anchors. The distal anchor then would simply passharmlessly through the patient's digestive system. As yet anotherexample, the medical practitioner may decide not to cinch the proximaland distal anchors post-deployment, thereby leaving the anchors in placewithout securing tissue fold F. Furtherstill, the medical practitionermay reverse cinching or cut the anchor assembly post-deployment, therebyreversing tissue fold formation.

[0163] As will be apparent to those of skill in the art, when anchordelivery system 250 is used in conjunction with previously describedapparatus 10, 175 or 200, to place an anchor assembly across fold Fformed by said apparatus, flexible delivery tube 252 may either compriseor be advanced through flexible tube 14, 177 or 177′, of apparatus 10,175 or 200, respectively. Likewise, needle 260 may comprise needle 34,92 or 92′, of apparatus 10, 175 or 200, respectively. Needle 260alternatively may comprise obturator 50 of FIGS. 5. As will be apparent,components of anchor delivery system 250 may also comprise or beadvanced through comparable components of alternative tissue foldingapparatus described hereinafter.

[0164] Referring now to FIGS. 22, an alternative anchor delivery systemis described. As with anchor delivery system 250 of FIGS. 21, anchordelivery system 300 of FIGS. 22 is adapted for use with the adjustableanchor assemblies of FIGS. 7-17. In FIGS. 22, the anchor delivery system300 is illustratively shown in use with anchor assembly 60 of FIGS. 7,but this should in no way be construed as limiting. Also, deliverysystem 300 may be used in conjunction with apparatus for forming atissue fold, such as apparatus 10, 175 and 200 described previously, oralternative apparatus described hereinafter, in order to anchor thetissue fold. Alternatively, the delivery system may be used for anyother application, or in conjunction with any other apparatus, requiringdelivery of an anchor assembly.

[0165]FIG. 22A illustrates a distal region of anchor delivery system300. System 300 comprises flexible delivery tube 302 having lumen 303.Flexible delivery tube 302 may be configured for insertion through apatient's mouth and esophagus into a gastrointestinal lumen, such as thestomach. Flexible delivery tube 302 preferably includes a plurality ofthrough-wall slots 304 to enhance flexibility of the tube, yet maintaintorqueability. Slots 304 may form bendable section 305. Preferably,flexible delivery tube 302 is made from stainless steel with an etchedor laser-cut slot pattern. The slot pattern is preferably a sinusoidalrepeating pattern of slots perpendicular to the longitudinal axis of thetube. Additional/alternative patterns will be apparent to those of skillin the art.

[0166] Flexible delivery tube 302 further comprises end region 306,which is coupled to anchor tube 307 having lumen or bore 308. As bestseen in FIG. 22B, lumen 308 of anchor tube 307 communicates with lumen303 of delivery tube 302 via through-slot 309. Proximal anchor 64 isdisposed within anchor tube 307, while distal anchor 62 is disposedwithin needle 260′, which sits within delivery tube 302.

[0167] Suture 39 passes out of needle 260′ from distal anchor 62 throughslot 266′. It then crosses from flexible delivery tube 302 to anchortube 307 via through-slot 309. After passing through proximal anchor 64,suture 39 is passed back to delivery tube 302 via the through-slot, andis threaded around anchor pushrod 280′, such that the loop of sutureformed by knot 69 on suture 39 is disposed between needle pushrod 270′and anchor pushrod 280′.

[0168] Needle 260′, needle pushrod 270′ and anchor pushrod 280′ aresubstantially the same as needle 260 and pushrods 270 and 280,respectively, which are described hereinabove with respect to anchordelivery system 250 of FIGS. 21. Furthermore, anchor assembly 60 may bedelivered from and adjusted by anchor delivery system 300 in a mannersimilar to that described hereinabove with respect to system 250.

[0169] In FIG. 22A, anchor tube 307 of anchor delivery system 300 isillustratively shown as a relatively short tube having lumen or bore 308adapted for disposal of proximal anchor 64 therein. However, it shouldbe understood that anchor tube 307, lumen 308 and/or through-slot 309alternatively may extend all or part of the way to a proximal end offlexible delivery tube 302 of delivery system 300. Advantageously, suchan arrangement facilitates loading of anchor assembly 60 from a proximalend of the anchor delivery system, e.g., for reloading of anchordelivery system 300 while a distal region of the system is disposedwithin a patient. Such an arrangement also may simplify manufacturing ofthe system.

[0170] Anchor delivery system 300 illustratively has been described witha single anchor assembly 60 disposed therein. However, it should beunderstood that a plurality of anchor assemblies may be loaded withindelivery system 300, thereby facilitating delivery of multiple anchorassemblies across different points of a tissue fold, across different(e.g., adjacent) tissue folds, or across other tissue structures. Theplurality of distal anchors 62 preferably are loaded within needle 262′of flexible delivery tube 302, while the plurality of proximal anchors64 preferably are loaded within lumen 308 of anchor tube 307.

[0171] An advantage of anchor delivery system 300, as compared to system250 of FIGS. 21, is that both the proximal and distal anchors arelocated distal of the bendable section of the delivery tube duringdelivery. This reduces an initial length of suture that must be disposedbetween the anchors, thereby reducing a length of unneeded sutureextending proximally of the proximal anchor post-delivery andadjustment. It also simplifies delivery by allowing both the proximaland distal anchors to be delivered while the bendable section of thedelivery tube is bent. Additionally, placement of the proximal anchor ina separate anchor tube eliminates a need to eject the needle from theflexible delivery tube on the proximal side of a tissue fold in order todeploy the proximal anchor, thereby reducing a risk of accidental tissuepuncture with the needle.

[0172] With reference to FIG. 23, another alternative anchor deliverysystem is described. As with anchor delivery systems 250 and 300 ofFIGS. 21 and 22, respectively, anchor delivery system 400 of FIG. 23 isadapted for use with the adjustable anchor assemblies of FIGS. 7-17.Anchor delivery system 400 is illustratively shown in use with anchorassembly 60 of FIGS. 7, but this should in no way be construed aslimiting. Also, delivery system 400 may be used in conjunction withapparatus for forming a tissue fold, such as apparatus 10, 175 and 200described previously, or alternative apparatus described hereinafter, inorder to anchor the tissue fold. Alternatively, delivery system 400 maybe used for any other application, or in conjunction with any otherapparatus, requiring delivery of an anchor assembly.

[0173]FIG. 23 illustrates a distal region of anchor delivery system 400.System 400 comprises flexible delivery tube 402 having lumen 403.Flexible delivery tube 402 may be configured for insertion through apatient's mouth and esophagus into a gastrointestinal lumen, such as thestomach. Flexible delivery tube 402 preferably includes a plurality ofthrough-wall slots to enhance flexibility of the tube, yet maintaintorqueability. The slots may form bendable section 405.

[0174] Anchor delivery system 400 further comprises delivery needle260″, which is disposed within lumen 403 of flexible delivery tube 402distal of bendable section 405 during delivery. As discussed previously,anchor delivery system 400 is illustratively described in conjunctionwith anchor assembly 60 of FIGS. 7. Needle 260″ preferably has a lengthsufficient for both distal anchor 62 and proximal anchor 64 of anchorassembly 60 to be disposed therein; for example, needle 260″ preferablyhas a length of less than about 5 cm, and even more preferably has alength of about 3 cm. Except for an increase in length, needle 260″ issubstantially the same as needle 260 of FIGS. 21.

[0175] In FIG. 23, both distal anchor 62 and proximal anchor 64 aredisposed within lumen 264″ of needle 260″. Suture 39 passes through andback through slot 266″ of the needle as the suture extends from distalanchor 62 to proximal anchor 64. Alternatively the length of suturebetween the proximal and distal anchors may be disposed within theneedle during delivery. Advantageously, both the proximal and distalanchors of anchor assembly 60 may be deployed through needle 260″ whilebendable section 405 is actuated or bent, e.g., while anchor deliverysystem 400 is used in conjunction with previously described plicationapparatus.

[0176] Needle 260″ is proximally coupled to flexible needle pushtube420, which facilitates translation of the needle beyond a distal end offlexible delivery tube 402. As will be apparent to those of skill in theart, needle 260″ and needle pushtube 420 optionally may be manufacturedas a single piece. Needle pushtube 420 comprises lumen 422, as well asskive 424 that communicates with lumen 422. Needle pushtube 420 extendsto a control actuator (not shown), which may be spring-loaded, disposedat a proximal end of anchor delivery system 400.

[0177] Anchor pushrod 280″, which is substantially the same as anchorpushrod 280 described previously, is removably disposed within lumen 422of needle pushtube 420 distal of skive 424. As with pushtube 420, anchorpushrod 280″ extends to a control actuator (not shown) disposed at aproximal end of the anchor delivery system. Suture 39 proximally extendsfrom proximal anchor 64 through slot 266″ of needle 260″, through skive424 and within lumen 422 of needle pushtube 420, around anchor pushrod280″ and out through skive 424 to knot 69. The proximal loop of sutureformed by knot 69 is trapped around pushrod 280″ and within lumen 422 ofthe needle pushtube, thereby facilitating unidirectional adjustment ofthe length of suture disposed between distal anchor 62 and proximalanchor 64. As an alternative to the proximal loop of suture, knot 69 maybe formed on the proximal end of suture 39, such that the knot istrapped between anchor pushtube 280″ and needle pushrod 420 (see knot Kof FIG. 24).

[0178] Anchor assembly 60 may be delivered, deployed and adjusted byanchor delivery system 400 in a manner similar to that describedhereinabove with respect to system 250 of FIGS. 21, with a fewalterations. Specifically, during deployment of distal anchor 62, anchorpushrod 280″ is advanced against proximal anchor 64, which in turnadvances in-line distal anchor 62. The pushrod is advanced a sufficientdistance with respect to needle 260″ to eject the distal anchor fromneedle lumen 264″, but not so far as to also prematurely eject proximalanchor 64. Motion limitation apparatus may be provided to ensure thatthe distal anchor is not prematurely ejected. Exemplary motionlimitation apparatus is described hereinbelow with respect to FIG. 24;additional apparatus, per se known, will be apparent.

[0179] In order to eject proximal anchor 64 from lumen 264″ of needle260″, either the needle is retracted until length L of suture 39disposed between the proximal and distal anchors is pulled taut andpulls the proximal anchor out of the needle lumen, or anchor pushrod280″ is advanced a sufficient distance within the lumen of needle 260″to eject the proximal anchor from the lumen (or a combination thereof).Additionally, in order to release anchor assembly 60 from anchordelivery system 400 post-delivery and adjustment, anchor pushrod 280″ isretracted proximal of skive 424 such that the loop of suture 39 formedby knot 69 is no longer trapped within lumen 422 of needle pushrod 420.Upon deployment of anchor assembly 60, delivery system 400 may beremoved from the patient. Alternatively, needle 260″ and needle pushrod420, as well as anchor pushrod 280″, may be removed from the patient,reloaded with a new anchor assembly, and re-advanced through flexibledelivery tube 402 for deployment of additional anchors withoutnecessitating removal of delivery tube 402 from the patient.

[0180] A significant advantage of anchor delivery system 400, ascompared to system 250 of FIGS. 21, is that both the proximal and distalanchors are disposed distal of bendable section 405 of flexible deliverytube 402. A significant advantage of anchor delivery system 400, ascompared to system 300 of FIGS. 22, is that both the proximal and distalanchors are disposed within needle 260″, thereby eliminating a need foran anchor tube and reducing a profile of the system.

[0181] Referring now to FIG. 24, an alternative embodiment of anchordelivery system 400 is described comprising motion limitation apparatus.Anchor delivery system 400′ is substantially the same as system 400,except that needle pushtube 420′ comprises two skives: motion limitationskive 430 and unidirectional adjustment skive 432, both of whichcommunicate with lumen 422′ of the needle pushrod. Suture 39 proximallyextends from proximal anchor 64, through motion limitation skive 430 andwithin lumen 422′ between anchor pushrod 280″ and needle pushtube 420′.Suture 39 exits skive 430 and is tied off at motion limitation knot K,which is trapped at skive 430 by anchor pushrod 280″. Suture 39 thencontinues proximally to unidirectional adjustment skive 432 and theproximal loop of suture formed by knot 69, which is trapped at skive 432around pushrod 280″.

[0182] A length of suture extending between proximal anchor 64 and knotK is specified such that distal anchor 62 may exit lumen 264″ of needle260″, but proximal anchor 64 cannot exit while knot K is trapped atskive 430 by anchor pushrod 280″. For example, during delivery of anchorassembly 60 across a tissue fold, advancement of pushrod 280″ advancesproximal anchor 64, which in turn advances in-line distal anchor 62until the distal anchor is ejected from needle lumen 264″ on the distalside of the tissue fold. Knot K limits a distance anchor pushrod 280″may be advanced and ensures that proximal anchor 64 is not prematurelydeployed.

[0183] Once anchor delivery system 400′ is again disposed on theproximal side of the tissue fold, anchor pushrod 280″ is retractedproximal of motion limitation skive 430, thereby allowing knot K toescape from skive 430 and facilitating deployment of proximal anchor 64.Proximal anchor 64 may be deployed by either retracting needle 260″until the length of suture between the two anchors is pulled taut andpulls the proximal anchor out of the needle, or by re-advancing pushrod280″ to push the proximal anchor out of the needle.

[0184] The anchor assembly may then be unidirectionally adjusted via thesuture loop trapped at skive 232, as described previously. Afteradjustment has been completed, anchor pushrod 280″ is retracted proximalof unidirectional adjustment skive 432, thereby allowing the loop ofsuture formed by knot 69 of suture 39 to escape from skive 432. As withanchor delivery systems 250 and 400 described previously, upondeployment of the anchor assembly, system 400′ may be removed from thepatient, or may be reloaded while flexible tube 402 remains in thepatient. A significant advantage of anchor delivery system 400′, ascompared to system 400 of FIG. 23, is that motion limitation skive 430reduces a risk of premature deployment of proximal anchor 64.

[0185] With reference to FIG. 25, yet another alternative anchordelivery system is described. Anchor delivery system 500 is adapted todeliver multiple adjustable anchor assemblies without necessitatingreloading or removal from a patient. Delivery system 500 may be used inconjunction with apparatus for forming a tissue fold or may be used forany other application, or in conjunction with any other apparatus,requiring delivery of an anchor assembly. In FIG. 25, anchor deliverysystem 500 is illustratively loaded with multiple anchor assemblies 60of FIGS. 7, but this should in no way be construed as limiting.

[0186]FIG. 25 illustrates a distal region of anchor delivery system 500.System 500 comprises flexible delivery tube 510, flexible needle tube520, anchor pushrod 530 and skive rod 540. Delivery tube 510, which issubstantially the same as delivery tube 402 described previously,comprises lumen 511 and optional bendable section 512. Needle tube 520comprises delivery needle 522, anchor lumen 523 and skive bore 524.Lumen 523 extends through needle tube 520 from its proximal end toneedle 522, and anchor pushrod 530, as well as anchor assemblies 60, isdisposed within the lumen. Bore 524 preferably terminates just proximalof needle 522; skive rod 540 is disposed within the bore. For ease ofmanufacturing, bore 524 optionally may be replaced with a lumen (notshown) that extends all the way to needle 522.

[0187] Needle tube 520 further comprises two through-slots and twoskives: first motion limitation through-slot 526 a, first unidirectionaladjustment skive 528 a, second motion limitation through-slot 526 b, andsecond unidirectional adjustment skive 528 b. The skives andthrough-slots all communicate with skive bore 524. Through-slots 526further communicate with anchor lumen 523 and provide passagewaysbetween the anchor lumen and skive bore 524. Skives 528 furthercommunicate with the exterior of needle tube 520 and provide passagewaysbetween the exterior and skive bore 524.

[0188] As discussed previously, anchor delivery system 500 isillustratively shown loaded with anchor assemblies 60. First anchorassembly 60 a and second anchor assembly 60b are disposed within anchorlumen 523, with assembly 60 a disposed distal of assembly 60 b. Anchorpushrod 530 is disposed proximal of second assembly 60 b within lumen523.

[0189] First suture 39 a of first anchor assembly 60 a proximallyextends within lumen 523 from first distal anchor 62 a to and throughfirst proximal anchor 64 a. Suture 39 a then extends from anchor lumen523 to skive bore 524 via first motion limitation through-slot 526 a.Suture 39 a loosely encircles skive rod 540 and is tied off to itself atfirst motion limitation knot K_(1A), such that the loop of suture formedby knot K_(1A) is trapped about skive rod 540. A length of suturedisposed between first proximal anchor 64 a and first motion limitationknot K_(1A) is sufficient to allow deployment of first distal anchor 62a from lumen 523 of needle tube 520, but is not long enough to allowdeployment of first proximal anchor 64 a from the lumen. Rather, thelength of suture is pulled taut with the loop formed by knot K_(1A)abutting first through-slot 526 a and trapped about skive rod 540. Inthis manner, the suture loop formed by knot K_(1A) provides motionlimitation when disposed about skive rod 540. Skive rod 540 may betranslated relative to the suture loop to release the loop from the rodafter deployment of first distal anchor 62 a.

[0190] From knot K_(1A), first suture 39 a continues proximally to firstunidirectional adjustment skive 528 a. Suture 39 a then once againloosely encircles skive rod 540 and is tied off to itself at firstunidirectional adjustment knot K_(1B). While disposed about skive rod540 at first skive 528 a, the loop of suture formed by knot K_(1B) maybe used to unidirectionally adjust first anchor assembly 60 apost-deployment, as described hereinabove. A length of suture disposedbetween first proximal anchor 64 a and first unidirectional adjustmentknot K_(1B) is sufficient to enable deployment of the anchor from lumen523 of anchor tube 520.

[0191] Second suture 39 b of second anchor assembly 60 b couples seconddistal anchor 62 b and second proximal anchor 64 b to second motionlimitation through-slot 526 b and second unidirectional adjustment skive528 b in a manner similar to that described with respect to first suture39 a of first anchor assembly 60 a. The loop of suture formed by secondmotion limitation knot K_(2A) precludes premature deployment of secondproximal anchor 64 b, while the loop of suture formed by secondunidirectional adjustment knot K_(2B) enables adjustment of a length ofsuture disposed between second distal anchor 62 b and second proximalanchor 64 b.

[0192] Anchor assemblies 60 a and 60 b may be delivered from, andadjusted by, anchor delivery system 500 in a manner similar to thatdescribed hereinabove with respect to system 400′ of FIGS. 24, with afew alterations. Specifically, during deployment of first distal anchor62 a, anchor pushrod 530 is advanced against second proximal anchor 64b, which in turn advances in-line second distal anchor 62 b and in-linefirst proximal anchor 64 a. The pushrod is advanced a sufficientdistance with respect to needle tube 520 to eject first distal anchor 62a from anchor lumen 523.

[0193] Additional advancement of pushrod 530 causes the suture loopformed by first motion limitation knot K_(1A) to catch against firstthrough-slot 526 a, thereby ensuring that first proximal anchor 64 a isnot prematurely ejected from lumen 523. When ready to deploy the firstproximal anchor, skive rod 540 may be retracted proximal of first motionlimitation through-slot 526 a, thereby freeing the loop of suture formedby knot K_(1A) from the skive rod. First proximal anchor 64 a may thenbe deployed by further distal advancement of the anchor pushrod againstsecond anchor assembly 60 b. The second anchor assembly advances firstproximal anchor 64 a out of needle 522.

[0194] First anchor assembly 60 a then may be unidirectionally adjustedas described hereinabove, using first skive 528 a, the loop of sutureformed by first adjustment knot K_(1B) and delivery tube 510. Onceadjusted, skive rod 540 may be further retracted within skive bore 524to a position proximal of first skive 528 a, thereby releasing firstanchor assembly 60 a from anchor delivery system 500. Second anchorassembly 60 b may then be deployed and adjusted in a similar mannerusing second through-slot 526 b, second skive 528 b and second knotsK_(2A) and K_(2B).

[0195] As will be apparent to those of skill in the art, although anchordelivery system 500 illustratively has been described in a configurationsuited for delivery of only two anchor assemblies, any number of anchorassemblies may be accommodated, for example, by adding additional pairsof motion limitation through-slots and unidirectional adjustment skivesto needle tube 520. Additionally, spacers, for example, digestiblespacers, wax spacers, polymer spacers, etc., may be provided betweenanchors and/or between anchor assemblies to reduce a risk of prematuredeployment of an anchor or assembly. Additional spacing and motionlimitation techniques will be apparent.

[0196] Referring now to FIG. 26, an alternative embodiment of anchordelivery system 500 is described. For the purposes of illustration,flexible delivery tube 510 has been omitted from system 500′ of FIG. 26.However, it should be understood that anchor delivery system 500′preferably comprises flexible delivery tube 510.

[0197] Anchor delivery system 500′ is substantially the same as system500, except that first and second through-slots 526a′ and 526b′ do notcommunicate with skive bore 524. Rather, through-slots 526′ provideopenings between anchor lumen 523 and the exterior of needle tube 520.Additionally, needle tube 520 further comprises first and second motionlimitation skives 527 a and 527 b, which constrain the loops of sutureformed by first and second motion limitation knots K_(1A) and K_(2A),respectively. It is expected that anchor delivery system 500′ will beeasier to manufacture than system 500. Additionally, enhanced suturemanagement is expected, since a substantial length of first suture 39 aand second suture 39 b is disposed outside of needle tube 520 withinlumen 511 of delivery tube 510 (see FIG. 25) during delivery. As withanchor delivery system 500, delivery system 500′ may be provided withspacers between anchors and/or anchor assemblies to reduce a risk ofpremature anchor deployment.

[0198] Anchor delivery systems 500 and 500′ of FIGS. 25 and 26,respectively, provide for delivery and deployment of multiple adjustableanchor assemblies from a linear stack of anchors disposed within a lumenof the needle tube. FIGS. 27 illustrate a first embodiment of analternative anchor delivery system wherein the multiple anchorassemblies are delivered and deployed from chambers of a radial stack orrevolver disposed about the needle tube, without necessitating reloadingor removal from the patient. Either the revolver or the needle tube (orboth) may be rotated to align the needle tube with successive chambersof the revolver for reloading the needle tube with anchor assembliesfrom the radial stack.

[0199] In FIGS. 27, anchor delivery system 600 comprises flexibledelivery tube 610, flexible needle tube 620, anchor pushrod 630 andrevolver 640. Flexible delivery tube 610 comprises lumen 612. Needletube 620 comprises needle 622, anchor loading slot 624, anchor lumen 626and plurality of adjustment skives 628. Skives 628 are disposed over alongitudinal length of needle tube 620 and optionally may be disposed atvarying radial positions about needle tube 620. Anchor pushrod 630 istranslatably disposed within anchor lumen 626 of needle tube 620 fordeployment and adjustment of anchor assemblies 60, and both needle 622and anchor slot 624 communicate with lumen 626. Revolver 640, comprisingplurality of chambers 642, preferably is coupled to, or is integralwith, flexible delivery tube 610. Chambers 642 communicate with lumen612 of flexible delivery tube 610.

[0200] Chambers 642 preferably are pre-loaded with plurality of anchorassemblies 60. Furthermore, lumen 626 of needle tube 620 preferably ispre-loaded with first anchor assembly 60 a. Sutures 39 extend proximallyfrom anchor assemblies 60 to skives 628, where sutures 39 form knottedsuture loops K that are reversibly constrained within lumen 626 ofneedle tube 620 by anchor pushrod 630, in order to facilitate adjustmentof the length of suture disposed between the proximal and distal anchorsof each assembly, as discussed previously.

[0201] Suture 39 a of first anchor assembly 60 a extends proximally fromfirst proximal anchor 64 a through anchor loading slot 624 to firstskive 628 a, where it forms first knotted suture loop K_(a). In use,anchor pushrod 630 may be used to deploy first anchor assembly 60 a fromlumen 626 of needle tube 620, for example, with distal anchor 62 adisposed on the distal side of a tissue fold and proximal anchor 64 adisposed on the proximal side. After adjustment in the manner describedpreviously, anchor pushrod 630 may be retracted proximally to a positionproximal of first skive 628 a, thereby freeing first knotted suture loopfrom lumen 626. Proximal retraction of anchor delivery system 600 withrespect to first anchor assembly 60 a completely removes suture 39 afrom the delivery system, thereby completing deployment of first anchorassembly 60 a.

[0202] As discussed previously, chambers 642 of revolver 640 communicatewith lumen 612 of flexible delivery tube 610. This facilitates loadingof successive anchor assemblies 60 within needle tube 620 bylongitudinally and radially aligning successive loaded chambers 642 ofrevolver 640 with anchor loading slot 624 of the needle tube. Needletube 620 and revolver 640 optionally may be initially aligned such thatsecond anchor assembly 60 b disposed in chamber 642 b drops throughanchor loading slot 624 into lumen 626 of anchor tube 620 uponretraction of anchor pushrod 630 proximal of anchor loading slot 624,e.g., while releasing first knotted suture loop K_(a) from lumen 626.Subsequent loading of anchor assembly 60 c, etc., post-deployment,-adjustment and -release of anchor assembly 60 b, may be achieved byrotating needle tube 520 with respect to revolver 540/delivery tube 510,or vice versa.

[0203] In this manner, plurality of anchor assemblies 60 may bedelivered and deployed without necessitating reloading or removal ofanchor delivery system 600 from the patient. In FIGS. 27, revolver 640illustratively is shown with three loaded chambers 642. However, anyalternative number of chambers and anchor assemblies may be provided, aswill be apparent to those of skill in the art. Additionally, optionalmotion limitation apparatus may be provided. Furthermore, detents,color-coding or other mechanisms may be provided to facilitate properradial and longitudinal alignment of delivery tube 610, needle tube 620(as well as anchor loading slot 624 and skives 628 of the needle tube),anchor pushrod 630 and revolver 640 (as well as successive chambers 642of the revolver) relative to one another.

[0204] With reference now to FIGS. 28-34, additional plication apparatusfor forming tissue folds is described. FIG. 28 illustrates analternative embodiment of apparatus 200 of FIGS. 20. Apparatus 200′ isadapted to simultaneously or sequentially form and approximate aplurality of tissue folds F within tissue wall W. Apparatus 200′ may beused in conjunction with any of the anchors and anchor delivery systemsdescribed hereinabove, as well as with any applicable alternativeanchors or systems, to secure the approximated tissue folds together. Itis expected that approximating and securing a plurality of tissue foldswill have substantial utility in performing a variety of medicaltreatments including, for example, gastric reduction.

[0205] In FIGS. 28, apparatus 200′ comprises a plurality ofarticulate-able, flexible tubes 177′, each with a tissue grabbingassembly 18′. Tubes 177′ preferably are biased such that the tubes flareoutward distal of sheath 650, thereby ensuring that the portions oftissue wall W plicated to form tissue folds F are separated by anappropriate distance prior to approximation, and that the tubesresiliently return to their flared position post-plication and releaseof tissue wall W. Tubes 177′ preferably may be translated relative tosheath 650. As seen in FIG. 28B, flexible tubes 177′ articulate inwardtoward a longitudinal axis of apparatus 200′ in order to form andapproximate tissue folds F. As will be apparent to those of skill in theart, a magnitude of the outward bias applied to tubes 177′ may bespecified such that an appropriate initial separation distance L betweenthe tissue grasping assemblies for a desired medical treatment isachieved. Furthermore, in order to reduce a delivery profile ofapparatus 200′, flexible tubes 177′ may be disposed within sheath 650(or another external sheath) during delivery.

[0206] With reference to FIG. 29, an alternative embodiment of apparatus10 of FIGS. 1 is described comprising backside stabilization. Allplication apparatus described hereinabove comprise a distal regionincluding a tissue grabbing assembly adapted to engage and stretch aportion of a tissue wall within a GI lumen at a first tissue contactpoint. A second tissue contact point then is established with the tissuewall at a location initially proximal of, or in line with, the firsttissue contact point. The tissue engaged by the tissue grabbing assemblythen is moved to a position proximal of the second tissue contact pointto form a tissue fold, and an anchor assembly may be delivered acrossthe tissue fold, e.g. across the muscularis and serosa layers of thetissue wall.

[0207] Apparatus 10′ of FIG. 29 is a first embodiment of apparatusadapted to establish a third tissue contact point at another locationinitially proximal of, or in line with, the first tissue contact point;additional embodiments will be described hereinbelow. Upon movement ofthe tissue engaged by the tissue grabbing assembly to a positionproximal of both the second and third tissue contact points, a tissuefold is formed with the second and third contact points on opposingsides of the fold. The second and third contact points provide bothfront and backside stabilization, respectively, of the tissue fold. Whendelivering an optional anchor assembly across the tissue fold from avicinity of the second tissue contact point, backside stabilization atthe third tissue contact point reduces backside tenting of tissue,thereby facilitating anchor delivery.

[0208] In FIG. 29, apparatus 10′ of the present invention comprisestorqueable catheter 11′, which may be configured, for example, forinsertion through a patient's mouth and esophagus into the patient'sgastrointestinal lumen. Catheter 11′ comprises distal region 12′ havingfirst and second interconnected flexible tubes 13 and 14 extendingtherefrom. Tubes 13 and 14 are joined by hinge assembly 20, and tissuegrabbing assembly 18 is disposed on the distal end of flexible tube 13.The tissue grabbing assembly is coupled to a control wire (not shown)that extends through tube 13 to a proximal region of catheter 11′ (notshown).

[0209] Distal region 12′ of apparatus 10′ is substantially the same asdistal region 12 of apparatus 10 of FIGS. 1, except that distal region12′ further comprises selectively deployable backside stabilizer 700.Backside stabilizer 700 comprises wire loop 710, which preferably isfabricated from a loop of shape memory material, e.g. Nitinol, coupledto control wire 720 that extends from wire tube 730. The proximal regionof catheter 11′ comprises actuators (not shown) in communication withthe tissue grabbing assembly control wire and control wire 720 foractuating the tissue grabbing assembly and the backside stabilizer,respectively.

[0210] Referring to FIGS. 30A-30E, a method of using apparatus 10′ ofFIG. 29 to form a backside stabilized tissue fold is described. In FIG.30A, apparatus 10′ is delivered to a treatment site through deliverysheath 740 with wire loop 710 compressed to a reduced deliveryconfiguration within the delivery sheath. In FIG. 30B, distal region 12′of catheter 11′ is advanced distal of delivery sheath 740, such thatwire loop 710 expands to a free-space configuration. In FIG. 30C,control wire 720 of backside stabilizer 700 is retracted proximally toretract wire loop 710 to an intermediate ready position. In FIG. 30D,tissue fold F is formed at tissue wall W with distal region 12′, e.g.,as described hereinabove with respect to FIGS. 3.

[0211] In FIG. 30E, tension is released from control wire 720, and wireloop 710 resiliently moves back towards its free-space configuration.Wire loop 710 of backside stabilizer 700 establishes a third tissuecontact point on the backside of tissue fold F, thereby providingbackside stabilization to the tissue fold. It is expected that backsidestabilization/establishment of an opposing third tissue contact pointwill simplify delivery of an anchor assembly across the tissue foldwhile facilitating formation and securing of a serosa-to-serosa fold.

[0212] As will be apparent to those of skill in the art, the size,length or diameter of wire loop 710 may be adjustable to facilitatebackside stabilization of tissue folds of variable size. Furthermore,wire loop 710 may may be provided as a substantially stagnant loop, i.e.the loop may not be retractable via control wire 720. In such aconfiguration, wire loop 710 would apply pressure to the tissue fold asit is formed, thereby facilitating formation of the fold in addition toproviding stabilization.

[0213] With reference now to FIGS. 31, further alternative tissuefolding apparatus comprising optional backside stabilization isdescribed. Apparatus 800 is adapted to linearly retract tissue at tissuewall W in order to form tissue fold F. The apparatus comprises catheter810 having tissue grabbing assembly 18; such as described hereinaboveand comprising a pair of jaws 28a, 28b having sharpened teeth 33arranged to rotate about pivot point 29 between an open configurationand a closed configuration; coupled to tube 820 having slot 822. Controlwire 19 is disposed within the lumen of tube 820 and extends from tissuegrabbing assembly 18 to a proximal end of apparatus 800 (not shown) foractuating the tissue grabbing assembly. Tissue grabbing assembly 18 isconfigured to establish a first tissue contact point with tissue wall Wand may be retracted proximally via tube 820 to facilitate formation oftissue fold F.

[0214] Apparatus 800 further comprises frontside and backside linkages830 a and 830 b, respectively. Proximal regions of the linkages arepivotably and translatably disposed within slot 822 of tube 820. Adistal region of frontside linkage 830 a is pivotably coupled to anchordelivery tube 840 for delivery of an anchor assembly across a tissuefold, as described previously, while a distal region of backside linkage830 b is pivotably coupled to backside stabilizer 850. Anchor deliverytube 840 and backside stabilizer 850 preferably are biased such thatthey substantially align with the longitudinal axis of apparatus 800when not under stress. Such alignment may be achieved, for example, byforming the elements from spring tube, or by providing the elements withresilient spines, e.g. Nitinol spines. Tube 840 and stabilizer 850 areconfigured to establish second and third tissue contact points,respectively, at tissue wall W, thereby providing frontside and backsidestabilization of a tissue fold formed at the wall, as describedhereinabove.

[0215] Referring again to FIGS. 31, a method of using apparatus 800 toform tissue fold F at tissue wall W is described. In FIG. 31A, tissuegrabbing assembly 18 has been advanced to a vicinity of tissue wall Wwith the proximal ends of linkages 830 disposed near the proximal end ofslot 822 in tube 820. Tissue grabbing assembly 18 is then actuated viaretraction of control wire 19 to grab tissue and establish the firsttissue contact point. With tissue engaged, continued retraction ofcontrol wire 19 causes proximal retraction of tube 820 and assembly 18in a substantially linear fashion relative to linkages 830, as seen inFIG. 31B.

[0216] As tube 820 is linearly retracted, linkages 830 slidablytranslate within slot 822 of the tube 820 until the proximal regions ofthe linkages contact a distal end of slot 822. As seen in FIG. 31C,further proximal retraction of tube 820 beyond this bottoming-out pointof slot 822 causes linkages 830 to rotatably pivot at both theirproximal and distal regions. This, in turn, causes anchor delivery tube840 and backside stabilizer 850 to rotate inwards and form the secondand third tissue contact points, respectively, thereby forming frontsideand backside-stabilized tissue fold F. Upon re-advancement of tube 820,anchor delivery tube 840 and backside stabilizer 850 resiliently realignwith the longitudinal axis of apparatus 800.

[0217] Previous plication apparatus described hereinabove require morecomplex motion than linear retraction on the part of the tissue grabbingassembly in order to form tissue fold F. It is expected that reducingmovement of the tissue grabbing assembly during tissue folding to alinear motion will reduce a magnitude of working space required at atreatment site to achieve formation of the tissue fold. As will beapparent to those of skill in the art, as an alternative to linearlyretracting tube 820 relative to linkages 830 in order to form tissuefold F, linkages 830 may be linearly advanced relative to tube 820.Also, backside linkage 830b and backside stabilizer 850 (as well asconcomitant backside stabilization of tissue fold F) optionally may beomitted. Alternatively, backside stabilizer 850 may comprise a secondanchor delivery tube, e.g., for delivery of an anchor assembly acrosstissue fold F from the backside, for passage of all or part of an anchorassembly from frontside anchor delivery tube 840 to the backsidestabilizer across the tissue fold, or for delivery of a multiplecomponent anchor assembly having a first component deployable from thefrontside anchor delivery tube and a second component deployable via thebackside stabilizer. The first and second components optionally may becoupled together to form a composite anchor assembly. Additionalconfigurations will be apparent to those of skill in the art.

[0218] Furthermore, slot 822 optionally may be omitted from tube 820,and the tube alternatively may be provided with proximal and distalstops disposed on the exterior of, or formed integral with, the tubenear its distal end. In this arrangement, the proximal ends of linkages830 would be pivotably and translatably disposed about the exterior oftube 820, such that the proximal and distal stops limit translation ofthe linkages relative to the tube. In both this arrangement and thearrangement of FIGS. 31, tube 820 acts as a linear bearing about whichlinkages 830 may travel.

[0219] With reference now to FIG. 32, an alternative embodiment ofapparatus 800 of FIG. 31 is described. Apparatus 800′ is substantiallythe same as apparatus 800, except that linkages 830 have been replacedwith control wires 830′, while slot 822 of tube 820 has been replacedwith skive 822′ of tube 820′. Additionally, anchor delivery tube 840′and backside stabilizer 850′ comprise optional pulley eyelets 860 a and860 b, respectively, for routing of control wires 830′. Control wires830′ are proximally coupled to control wire 19 of tissue grabbingassembly 18 within the lumen of tube 820′. Control wires 830′ exit thelumen at skive 822′ and extend distally through optional pulley eyelets860. Control wire 830 a′ is distally coupled to anchor delivery tube840′, while control wire 830 b′ is distally coupled to backsidestabilizer 850′.

[0220] A length of control wires 830′ is specified such that retractionof control wire 19 causes actuation of tissue grabbing assembly 18 andretraction of tube 820′, prior to control wires 830′ being pulled taut.Once control wires 830′ have been pulled taut, continued retraction ofcontrol wire 19 causes control wires 830′ to reversibly rotate anchordelivery tube 840′ and backside stabilizer 850′ inward, thereby formingthe second and third tissue contact points and forming frontside- andbackside-stabilized tissue fold F at tissue wall W. As with apparatus800, backside stabilizer 850′ (as well as associated control wire 830b′) of apparatus 800′ optionally may be omitted.

[0221] Referring to FIGS. 33 further alternative tissue foldingapparatus comprising optional backside stabilization is described.Apparatus 900 comprises outer tube 910 having distal region 912 withrigid or resilient frontside and backside stabilizers 914 a and 914 b,respectively. When substantially rigid, stabilizers 914 may be formed,for example, from a shaped stainless steel wire or rod. When resilient,the stabilizers may be formed, for example, from a wire or rod of shapememory material such as Nitinol or from a thinner wire or rod ofstainless steel. The durometer of the material used to fabricatestabilizers 914 may be specified to achieve a desired degree of rigidityor resiliency.

[0222] Apparatus 900 further comprises inner tube 920, which iscoaxially and slidably disposed within outer tube 910. Tissue grabbingassembly 922, coupled to a distal region of inner tube 910, compriseshelical coil 924 having sharpened distal tip 925. Helical coil 924 isadapted to reversibly engage tissue by reversibly screwing the coil intothe tissue in a manner similar to a wine corkscrew, and as demonstratedby arrows in FIG. 33A. As will be apparent to those of skill in the art,as an alternative or adjunct to helical coil 924, tissue grabbingassembly 922 may comprise a jaw structure similar to that of assembly18; likewise any of the previously described tissue folding apparatusoptionally may comprise a tissue grabbing assembly having a helicalcoil. Additional tissue grabbing assemblies, per se known, will beapparent in view of this disclosure.

[0223] FIGS. 33 illustrate a method of forming a tissue fold withapparatus 900. In FIG. 33A, tissue grabbing assembly 922 is advanceddistal of stabilizers 914 to engage tissue at tissue wall W at a firsttissue contact point. Helical coil 924 is screwed into the tissue, andinner tube 920 is then retracted relative to outer tube 910, and/or theouter tube is advanced relative to the inner tube, such that tissueengaged by assembly 922 is pulled proximal of stabilizers 914, as seenin FIG. 9B. Stabilizers 914 contact the tissue at second and thirdcontact points, and form frontside- and backside-stabilized tissue foldF. When rigid, a cross-sectional width of tissue fold F may be specifiedby a separation distance between the frontside and backside stabilizers.When resilient, the stabilizers may bow outward to facilitate formationof the tissue fold by decreasing a pulling force required by coil 924 toform the fold, as well as by reducing a risk of the coil detaching from,or tearing through, the tissue during fold formation.

[0224] As will be apparent to those of skill in the art, one ofstabilizer 914 a and stabilizer 914 b optionally may be omitted whenonly a second tissue contact point is required. Additionally, apparatus900 may be used in conjunction with an anchor delivery system, such asthose described previously; the anchor delivery system optionally mayprovide the third tissue contact point. Also, one or both of stabilizers914 may be extendable/retractable relative to distal region 912 of outertube 910 of apparatus 900. Likewise, the stabilizers may be sizable invivo to facilitate formation of a tissue fold of specified magnitude.

[0225] With reference now to FIGS. 34, another embodiment of plicationapparatus comprising backside stabilization is described. In contrast topreviously described apparatus, apparatus 950 achieves backsidestabilization of a tissue fold via tissue contact over an arcuatesegment, as opposed to at discrete points or along a line. In FIGS. 34,full 360° radial contact around the fold is established; however, aswill be apparent to those of skill in the art, contact alternatively maybe established at one or more locations over one or more arcuatesegments of less than 360°.

[0226] Apparatus 950 comprises inner tube 960 and coaxially disposedouter tube 970. Inner tube 960 comprises tissue grabbing assembly 18coupled to a distal of the tube. Apparatus 950 further comprises braidedmesh 980 having proximal end 982 coupled to a distal end of outer tube970, and distal end 984 coupled to inner tube 960 proximal of tissuegrabbing assembly 18. Braided mesh 980 preferably is fabricated frompolymer or metal wires. Upon advancement of outer tube 970 relative toinner tube 960, the mesh may be everted, e.g. over a tissue fold, toprovide frontside and backside stabilization of a fold via arcuatecontact. As will be apparent, apparatus 950 may be used in conjunctionwith an anchor delivery system to secure a stabilized tissue fold.

[0227] FIGS. 34 illustrate a method of using apparatus 950 to form astabilized tissue fold. In FIG. 34A, tissue grabbing assembly 18 engagestissue wall W at a first tissue contact point. In FIG. 34B, with tissueengaged by assembly 18, inner tube 960 is retracted relative to outertube 970 and/or outer tube 970 is advanced relative to inner tube 980,such that proximal end 982 is advanced distal of distal end 984 ofbraided mesh 980. The braided mesh everts about tissue fold F, therebyproviding frontside and backside stabilization to the tissue fold viacontact over a full 360° radial segment (braided mesh 980 shown insection in FIG. 34B).

[0228]FIGS. 29-34 have illustrated exemplary plication apparatuscomprising optional elements for backside stabilizing tissue foldsformed with the apparatus. As will be apparent to those of skill in theart, backside stabilization elements optionally may also be providedwith any other plication apparatus of the present invention.Furthermore, backside stabilization elements may be provided with anyanchor delivery system, e.g., in order to reduce tissue tenting duringdeployment of an anchor assembly across a tissue fold.

[0229] With reference now to FIGS. 35-39, an embodiment of ashape-lockable guide for use with tools of the present invention isdescribed. Shape-lockable guides have been described previously inApplicant's co-pending U.S. patent application Ser. No. 10/173,203,filed Jun. 13, 2002, which is incorporated herein by reference in itsentirety and from which the present invention claims priority. Asdiscussed hereinabove, a significant indication for use of the tissuegrabbing assemblies, plication apparatus, anchor delivery systems andanchor assemblies of the present invention is within a patient'sgastrointestinal (“GI”) lumen. However, the GI lumen variessignificantly in geometry and material properties along its length, andit is expected that properly positioning, as well as visualizing,endoluminal tools of the present invention at any desired locationwithin the GI lumen will present significant challenges. Transmittingforces and torques to the tools over substantial separation distancesbetween a medical practitioner and the working ends of the tools withinthe GI lumen presents additional challenges. It therefore would be niceto provide guide apparatus capable of providing exposure or targeting,stability, and flexibility to tools of the present invention whendisposed within a patient.

[0230] Apparatus 1000 of FIGS. 35-39 addresses these challenges byfacilitating placement of a diagnostic instrument, such as an endoscope,e.g., a colonoscope or gastroscope; and/or a therapeutic instrument,such as those described hereinabove; through the tortuous orunpredictably supported anatomy of a hollow body organ, such as thecolon, esophagus and/or stomach; while reducing a risk of distending orinjuring the organ. Apparatus 1000 permits such instruments to bereadily advanced into the patient's tortuous or unpredictably supportedanatomy by selectively shape-fixing an overtube portion of theapparatus, while also preventing tissue from being captured or pinchedbetween the overtube and the instrument(s). Although apparatus 1000illustratively comprises an overtube, it should be understood thatapparatus 1000 alternatively may comprise a selectively rigidizable,shape-fixing or shape-locking guide wire or inner conduit, over whichdiagnostic or therapeutic instruments may be advanced.

[0231] Referring now to FIG. 35, apparatus 1000 of the present inventionis described. Apparatus 1000 comprises handle 1001, overtube 1002, anddistal region 1003 having atraumatic tip 1004. Handle 1001 includeslumen 1005 that extends from Toughy-Borst valve 1006 through overtube1002, distal region 1003 and atraumatic tip 1004. Lumen 1005 isconfigured to facilitate passage of a standard commercially availableendoscope, such as endoscope 1100 having steerable distal tip 1101 (seeFIG. 40), and/or a therapeutic device of the present invention, e.g. atissue grabbing assembly, plication apparatus, an anchor deliverysystem, or an anchor assembly, therethrough. Although apparatus 1000illustratively comprises a single lumen, multiple lumens optionally maybe provided for passage of multiple diagnostic and/or therapeuticinstruments. Toughy-Borst valve 1006 may be actuated to releasably lockinstrument(s) to apparatus 1000 when the instrument(s) are insertedwithin lumen 1005. As described hereinafter, overtube 1002 is configuredso that it can be selectively transitioned between a flexible state anda rigid, shape-fixed state by actuator 1007 disposed on handle 1001.

[0232] In FIG. 36, an illustrative embodiment of overtube 1002 comprisesa multiplicity of nestable elements 1010. For purposes of illustration,nestable elements 1010 are shown spaced-apart, but it should beunderstood that elements 1010 are disposed so that their adjacentsurfaces 1011 and 1012 coact. Each of nestable elements 1010 has centralbore 1013 to accommodate diagnostic and therapeutic instruments, andpreferably three or more tension wire bores 1015. When assembled asshown in FIG. 35, nestable elements 1010 are fastened with adjacentsurfaces 1011 and 1012 disposed in a coacting fashion by a plurality oftension wires 1016 that extend through tension wire bores 1015.

[0233] In a preferred embodiment, adjacent surfaces 1011 and 1012 ofeach nestable element 1010 are contoured to mate with the next adjacentelement, so that when tension wires 1016 are relaxed, surfaces 1011 and1012 can rotate relative to one another. Tension wires 1016 are fixedlyconnected to the distal end of overtube 1002 at their distal ends and toa tensioning mechanism disposed within handle 1001 at their proximalends. When actuated by actuator 1007, tension wires 1016 impose a loadthat clamps adjacent surfaces 1011 and 1012 of nestable elements 1010together at the current relative orientation, thereby fixing the shapeof overtube 1002.

[0234] When the load in tension wires 1016 is released, tension wires1016 provide for relative angular movement between nestable elements1010. This in turn renders overtube 1002 sufficiently flexible tonegotiate a tortuous path or unpredictably supported anatomy through,for example, any region of a patient's GI lumen, such as the colon,esophagus and/or stomach. When the tensioning mechanism is actuated,however, tension wires 1016 are retracted proximally to apply a clampingload to the nestable elements. This load prevents further relativemovement between adjacent elements 1010 and stiffens overtube 1002, sothat any distally directed force applied to instruments within lumen1005 causes the working ends of the instruments to advance further intothe GI lumen, rather than cause overtube 1002 to bear against the wallof the lumen or lose its spatial orientation within an unpredictablysupported space. The shape-fixed overtube absorbs and distributes vectorforces, shielding the GI lumen.

[0235] Referring now to FIG. 37, an illustrative embodiment of distalregion 1003 and atraumatic tip 1004 is described. Distal region 1003comprises flexible, kink-resistant coil 1021 encapsulated in flexiblelayer 1022. Layer 1022 preferably comprises a soft elastomeric andhydrophilic coated material, such as silicon or synthetic rubber, andextends through bores 1013 of nestable elements 1010 to form liner 1023for lumen 1005. Layer 1022 extends to handle 1001 at the proximal end,and at the distal end terminates in enlarged section 1024 that formsatraumatic tip 1004.

[0236] Layer 1022 preferably joins with or is integrally formed withflexible elastomeric cover 1025 which encapsulates nestable elements1010 in annular chamber 1026. Cover 1025 provides a relatively smoothouter surface for overtube 1002, and prevents tissue from being capturedor pinched during relative rotation of adjacent nestable elements 1010.

[0237] In accordance with one aspect of the present invention, endoscope1100 may be positioned with its distal tip 1101 disposed in distalregion 1003, so that deflection of steerable distal tip 1101 imparts anangular deflection to distal region 1003 and atraumatic tip 1004. Toensure that there is no gross relative motion between endoscope 1100 orother instruments within lumen 1005 and apparatus 1000, Toughy-Borstvalve 1006 is tightened to engage apparatus 1000 to theendoscope/instruments. In this manner, the instrument(s) and distalregion 1003 may be simultaneously advanced through the colon, with thedistal tip of endoscope 1100 providing a steering capability toapparatus 1000. Apparatus 1000 therefore may be advantageously advancedtogether with instruments disposed within lumen 1005 when overtube 1002is in the flexible state, reducing relative motion between apparatus1000 and such instruments to those instances where overtube 1002 must beshape-locked to prevent distension or to maintain distal region 1003orientation with the GI lumen.

[0238] Still referring to FIG. 37, terminations 1027 of tension wiresare described. Terminations 1027 illustratively comprise balls welded ormolded onto the ends of tension wires 1016 that ensure the tension wirescannot be pulled through tension wire bores 1015 of the distalmostnestable element 1010. This ensures that the nestable elements cannotcome loose when overtube 1002 is disposed within a patient.

[0239] Alternatively, terminations 1027 may comprise knots formed in theends of tension wires 1016, or any suitable fastener that prevents thetension wires from being drawn through the tension wire bores of thedistal-most nestable element. Advantageously, cover 1025 providesadditional assurance that all of nestable elements 1010 can be safelyretrieved from a patient's colon in the unlikely event of a tension wirefailure.

[0240] Referring now to FIGS. 35 and 38, tension wires 1016 withinovertube 1002, liner 1023 and lumen 1005 extend from distal region 1003,through overtube 1002, and to handle 1001. Within handle 1001, eachtension wire 1016 passes through wire lock release 1031 fixedly attachedto handle 1001, and wire lock 1032 disposed on slide block 1033. Eachtension wire 1016 terminates at wire tension spring 1034, whichmaintains tension wires 1016 in light tension even when overtube 1002 isin the flexible state. The degree of tension provided by wire tensionsprings 1034 is not sufficient to clamp adjacent nestable elements 1010together, but on the other hand does not let gaps form between adjacentnestable elements, and helps to manage the tension wire take up or slackas overtube 1002 makes various bends.

[0241] Slide block 1033 is keyed to slide along rail 1035 disposedbetween limit blocks 1036 and 1037, and comprises a rigid block having abore through which rail 1035 extends and an additional number of boresas required for the number of tension wires 1016 employed. Rack gear1038 is fixedly coupled to slide block 1033. Rack 1038 mates with piniongear 1039, which is in turn driven by bi-directional pawl 1040 coupledto actuator 1007. Pinion gear 1039 may be selectively engaged by eitherprong 1041 or 1042 of bidirectional pawl 1040, depending upon theposition of selector switch 1043.

[0242] If prong 1041 is selected to be engaged with pinion gear 1039, asqueezing action applied to actuator 1007, illustratively hand grip1044, causes rack 1033 to move in the D direction in FIG. 38, therebyapplying tension to tension wires 1016. Repeated actuation of hand grip1044 causes slide block 1033 to move progressively further in directionD, thereby applying an increasing clamping load on nestable elements1010. Any slack lengths of tension wires 1016 extending below slideblock 1033 are taken up by wire tension springs 1034. As discussed ingreater detail below with respect to FIG. 39, wire locks 1032, which areaffixed to slide block 1033, engage and retract tension wires 1016concurrently with movement of slide block 1033 in the D direction.

[0243] If prong 1042 is instead chosen by selector switch 1043 to engagepinion gear 1039, repeated actuation of hand grip 1044 causes slideblock 1033 to translate in direction U, thereby relaxing the tensileload applied by tension wires 1016 to nestable elements 1010. Repeatedactuation of hand grip 1044 causes slide block 1033 to advance indirection U until wire lock releases 1031 engage wire locks 1032,releasing all tension from tension wires 1016 except that provided bywire tension springs 1034. This action permits the clamping forcesimposed on nestable elements 1010 to be progressively reduced and renderovertube 1002 progressively move flexible, until when wire lock releases1031 engage wire locks 1032, the overtube is returned to its mostflexible state.

[0244] Referring to FIG. 39, wire lock 1032 and lock release 1031 aredescribed in greater detail. Wire lock 1032 includes jaws 1045 disposedwithin collet 1046. Collet 1046 includes a tapered conical bore 1047.Jaws 1045 have ramped exterior surfaces 1048 and teeth 1049, and arebiased against the surface formed by the tapered conical bore by springs70. Teeth 1049 are configured to engage tension wire 1016 under the biasforce of springs 70. When slide block 1033 is moved in direction D (seeFIG. 38), jaws 1045 engage and grasp tension wire 1016 and retract thetension wire in direction D.

[0245] To disengage teeth 1049 from tension wire 1016, e.g., when it isdesired to allow overtube 1002 to return to a flexible state, slideblock 1033 is actuated as described previously to move in direction U.Further actuation of slide block 1033 towards limit block 1036 and wirelock release 1031 causes wire lock release 1031 to extend into taperedconical bore 1047 and push jaws 1045 backward against the bias ofsprings 70. Once tension wires 1016 are freed from jaws 1045, overtube1002 returns to its most flexible state.

[0246] In FIGS. 35-39, apparatus 1000 has been described as having aflexible state and rigid state. However, it should be understood thatapparatus 1000 optionally may comprise one or more intermediary stateswherein overtube 1002 is only partially flexible or only partiallyrigid. Furthermore, overtube 1002 optionally may comprise one or moresections of varied rigidity or flexibility in either the flexible or therigid state, or both, as compared to one or more other sections of theovertube. For example, at least one section of the overtube may remainin the flexible state upon transition of the overtube to the rigidstate. Alternatively, at least one section of the overtube may comprisevaried rigidity relative to a different section of the overtube when theovertube is disposed in the rigid state. As yet another alternative, atleast one section of the overtube may comprise varied flexibilityrelative to a different section of the overtube when the overtube isdisposed in the flexible state. Additional configurations will beapparent to those of skill in the art.

[0247] It should be understood that apparatus 1000 optionally may beprovided with steering capabilities in addition to locking capabilities,in order to properly position apparatus 1000 within a GI lumen, e.g.prior to locking the overtube in a desired orientation. Such steeringcapabilities may be achieved, for example, using tensioning orstiffening wires, per se known. Additional steering techniques will beapparent to those of skill in the art.

[0248] As an alternative, or in addition, to advancing diagnostic and/ortherapeutic instruments through one or more lumens of apparatus 1000,such instruments optionally may be coupled to apparatus 1000. Forexample, an endoscope, a tissue grabbing assembly, plication apparatusand/or an anchor delivery system in accordance with the presentinvention, may be coupled to distal region 1003 of apparatus 1000.Alternatively, such instruments may be telescopically disposed andadvanced from within distal region 1003. Coupling instruments or toolsto a shape-lockable guide is described in more detail, for example, inApplicant's co-pending U.S. patent application Ser. No. 10/458,060,filed Jun. 9, 2003, which is incorporated herein by reference in itsentirety and from which the present invention claims priority.Additional configurations will be apparent to those of skill in the art.

[0249] With reference now to FIGS. 40, in conjunction with FIGS. 41, amethod of performing endoluminal gastric reduction is describedutilizing a system of tools illustratively comprising commerciallyavailable gastroscope 1100, plication apparatus 10 of FIGS. 1-3, anchordelivery system 250 of FIGS. 21 loaded with anchor assembly 60 of FIGS.7, and shape-lockable apparatus 1000 of FIGS. 35-39. Gastric reductionis a technique for reducing a patient's appetite and/or ability toingest food by reducing a volume of the stomach through which food maypass. Endoluminal gastric reduction in accordance with the presentinvention entails partitioning the stomach into first and secondchambers, and more specifically into a small lumen or pouch and a largerchamber, over at least a portion of the stomach.

[0250] The lumen/pouch preferably has a volume of approximately 10-50cm³, and even more preferably a volume of approximately 15 cm³, and ispositioned near and inferior to the patient's gastroesophageal junction.Ingested food may only pass through the small lumen over the partitionedportion of the stomach. The lumen preferably is formed by approximatingopposing anterior and posterior segments of the patient's stomach wallover a length or arc of the wall near and inferior to thegastroesophageal junction.

[0251] As illustrated in FIGS. 40 and 41, endoscopic gastric reductionmay be achieved by endoscopically forming, approximating and securing aplurality of tissue folds in a first plane within a patient's stomach,then endoscopically forming, approximating and securing at least oneadditional plurality of tissue folds in at least one substantiallyparallel plane within the patient's stomach. The first plurality oftissue folds and the at least one additional plurality of tissue foldsmay be attached or detached from one another. Each plurality of foldspreferably comprises one or more tissue folds from opposing anterior andposterior segments of the stomach near and inferior to thegastroesophageal junction.

[0252] More, specifically, endoscopic gastric reduction may be achievedby advancing an overtube through a patient's esophagus into thepatient's stomach while the overtube is disposed in a flexible state,then transitioning the overtube to a rigid state in a desiredorientation within the patient's stomach. A plication device, eithercoupled to the overtube or advanced therethrough, may then be used toform the plurality of tissue folds, while an anchor delivery system maybe used to approximate and/or secure the tissue folds, therebypartitioning the patient's stomach.

[0253] In FIGS. 40, overtube 1002 of shape-lockable apparatus 1000illustratively comprises first and second lumens 1005a and 1005b forpassage of gastroscope 1100 and plication apparatus 10/anchor deliverysystem 250, respectively. In FIG. 40A, optional thin wall sheath 2000 isdisposed within a patient's gastrointestinal lumen through the patient'smouth, into esophagus E, past the gastroesophageal junction GE, and intothe patient's stomach S. Shape-lockable overtube 1002 of apparatus 1000is advanced through sheath 2000 into stomach S while disposed in theflexible state. Sheath 2000 provides a barrier between overtube 1002 andesophagus E, which may facilitate increased maneuverability of apparatus1000 by protecting the esophagus during optional torqueing, translationand/or articulation of overtube 1002.

[0254] In FIG. 40A, gastroscope 1100 illustratively has been advancedthrough lumen 1005 a of overtube 1002 past distal region 1003 while theovertube is disposed in the flexible state. As will be apparent to thoseof skill in the art, a visualization element alternatively oradditionally may be coupled to overtube 1002; multiple pointvisualization may facilitate complex procedures and/or enabletriangulation for deployment of anchor assemblies across tissue folds.Furthermore, plication apparatus 10 and anchor delivery system 250optionally may be coupled to the overtube or may be advanced through theovertube while the tube is disposed in the flexible state.

[0255] In FIG. 40B, overtube 1002 is articulated to an orientationwhereby distal region 1003 facilitates engagement of tissue near andinferior to the patient's gastroesophageal junction GE. Sucharticulation may be achieved, for example, by actuating steerable distaltip 1101 of gastroscope 1100. Alternatively, apparatus 1000 may comprisesteering features. As yet another alternative, a steering tool, such asa shaped wire, may be advanced through second lumen 1005 b to properlyorient the overtube. Furtherstill, the overtube may comprise apre-formed flexible shape whereby the overtube assumes an arcuateconfiguration, and a rigid wire may be reversibly disposed with secondlumen 1005 b of overtube 1002 in order to straighten the overtube duringinsertion through esophagus E; upon positioning of distal region 1003 ofapparatus 1000 within stomach S, the wire may be removed from the lumen,such that overtube 1002 re-assumes its pre-formed shape. As yet anotheralternative, plication apparatus 10 and/or anchor delivery system 250may comprise steering features and may be advanced through the secondlumen to steer the overtube into position.

[0256] With apparatus 1000 disposed in the desired configuration ororientation, the apparatus is reversibly shape-locked to a rigid stateas described previously, such that the apparatus maintains its positionwithin the stomach. Preferably, the articulated portion of apparatus1000 traverses an arc of substantially continuous radius of curvature inthe shape-locked configuration, thereby reducing a magnitude of forcesrequired to advance and retract instruments through overtube 1002. In apreferred embodiment, the arc traverses approximately 270° and has aradius of curvature between about 5 and 10 cm, and, even morepreferably, approximately 7-8 cm. By retroflexing about 270°, distalregion 1003 of apparatus 1000 is directed back towards the body ofovertube 1002 near and inferior to gastroesophageal junction GE.

[0257] Plication apparatus 10 and anchor delivery system 250 areadvanced through second lumen 1005 b of overtube 1002 distal of distalregion 1003 (alternatively, the plication apparatus and anchor deliverysystem may be coupled to the overtube). As seen in FIG. 40C, e.g. undervisualization provided by gastroscope 1100, tissue is engaged withinstomach S using tissue grabbing assembly 18. Tissue fold F is formed,for example, as described previously with respect to FIGS. 3. Anchorassembly 60 then is deployed across the tissue fold via anchor deliverysystem 250 and is adjusted to secure the fold, for example, as describedhereinabove with respect to FIGS. 21.

[0258] As discussed previously and seen in FIGS. 41, in order to achieveendoluminal gastric reduction, opposing anterior An and posterior Posurfaces of stomach S are drawn together to partition the stomach intofirst lumen or pouch P and second larger chamber C. As seen in FIG. 41C,in order to achieve such partitioning, a plurality of folds is formed onthe opposing surfaces in a first plane P₁. The opposing folds areconnected by suture 39 or by other means and are approximated, forexample, by reducing a length of suture disposed between the opposingsurfaces, to partition the stomach as in FIG. 41B.

[0259] Optionally, at least one additional plurality of folds may beformed on the opposing anterior An and posterior Po surfaces in at leastone additional plane that is substantially parallel to first plane P₁.FIGS. 40D and 41C comprise optional additional pluralities of tissuefolds in second and third planes P₂ and P₃. In effect, an anterior ridgeAR of tissue folds is formed, and an opposing posterior ridge PR oftissue folds is formed. These additional pluralities of tissue folds maybe attached to the first plurality of tissue folds, as in FIG. 41C, ormay be unattached. Upon approximation of the tissue folds, for example,via cinching of suture 39, pouch P is formed, and endoluminal gastricreduction is achieved.

[0260] The number of planes in which pluralities of tissue folds areformed may be specified based on a preferred longitudinal spacing ofanchor assemblies and/or based upon a desired length of pouch P. Thedesired length L may be specified based on a desired volume V of pouch Pand a diameter D of pouch P, according to the following equation:

L=4V/(πD ²)  (1)

[0261] For example, overtube 1002 preferably has an outer diameter ofapproximately 1.6 cm. Thus, the diameter of pouch P must be at least 1.6cm, so that the overtube may pass through the pouch. Assuming a pouchdiameter of approximately 1.6 cm, and in order to provide the pouch witha volume of about 15 cm³, a length of pouch P should be about 7.5 cm.

[0262] Referring again to FIG. 40C, in order to form, secure andapproximate tissue folds on opposing anterior An and posterior. Posurfaces of stomach S, as well as in multiple planes P_(x), overtube1002 preferably comprises multiple degrees of freedom. Arrows in FIG.40C describe illustrative directions in which apparatus 1000 may bemaneuvered to re-orient or reconfigure overtube 1002. Specifically,apparatus 1000 may be translated relative to esophagus E and sheath2000, as described by arrow Tr. Furthermore, apparatus 1000 may betorqued, as described by arrow To. Furtherstill, the apparatus may bearticulated, as described by arrow ARt. As will be apparent, additionalor alternative degrees of freedom optionally may be provided.

[0263] As an example, a medical practitioner translating or torqueinghandle 1001 of apparatus 1000 from external to the patient may achievetranslation and torqueing of overtube 1002. Articulation may be achievedby a number of means, such as steering features provided within overtube1002, e.g. a tensioning wire, or by temporarily returning overtube 1002to the flexible state, actuating steerable end 1101 of gastroscope 1100to articulate overtube 1002 to a desired configuration, then once againshape-locking overtube 1002 to the rigid state. Combinations oftorqueing, translation and articulation may be used to position overtube1002 in any desired configuration.

[0264] In FIG. 40D, by repositioning overtube 1002, re-loading anchordelivery system 250, and re-actuating plication apparatus 10 and anchordelivery system 250, tissue folds have been formed, secured andapproximated on opposing surfaces in multiple planes, thereby formingpouch P and chamber C within stomach S. Overtube 1002 has beentransitioned back to the flexible state, and all instruments advancedthrough the overtube have been removed from apparatus 1000. Overtube1002 and optional sheath 2000 now may be removed from stomach S andesophagus E through pouch P, thereby completing endoluminal gastricreduction.

[0265] With reference now to FIGS. 42, a method of treatinggastroesophageal reflux disease (“GERD”) using the system of toolsdescribed with respect to FIGS. 40 is provided. Apparatus 1000 isadvanced through a patient's esophagus E with overtube 1002 disposed ina flexible state. Once again, optional sheath 2000 may be providedbetween esophagus E and apparatus 1000. The apparatus is thenmanipulated, for example, as described hereinabove, into a configurationenabling access to tissue in a vicinity of the patient'sgastroesophageal junction GE. Overtube 1002 is then shape-locked to arigid state, as seen in FIG. 42A.

[0266] In FIG. 42B, plication apparatus 10 (either advanced through orcoupled to apparatus 1000) is used to form tissue fold F₁ on a firstside of gastroesophageal junction GE. Anchor assembly 60, which isdeployed and adjusted via anchor delivery system 250, secures the tissuefold. Visualization of the procedure is achieved, for example, viagastroscope 1100.

[0267] Tissue fold F₁ provides a flap that reduces reflux of acid orother stomach materials into esophagus E. In patients with more seriousconditions, it may be necessary to provide one or more additional foldsaround gastroesophageal junction GE. For example, apparatus 1000 may berepositioned, anchor delivery system 250 reloaded, and opposing fold F₂formed, as in FIG. 42C. After a desired pressure differential has beenestablished across gastroesophageal junction GE, overtube 1002 may bereturned to the flexible state, and apparatus 1000, as well as anyinstruments advanced therethrough or coupled thereto, may be removedfrom the patient, thereby providing endoluminal treatment ofgastroesophageal reflux disease. Optionally, first and second pressuresensors Pr₁ and Pr₂ may be provided along the length of apparatus 1000to measure the pressure differential across gastroesophageal junctionGE, as seen in FIG. 42B. In use, first pressure sensor Pr₁ may bepositioned distal of the junction within the patient's stomach S, whilesecond pressure sensor Pr₂ is disposed proximal of the junction withinthe patient's esophagus E. Additional or alternative sensors will beapparent to those of skill in the art.

[0268] With reference now to FIGS. 43, an alternative method forachieving endoluminal gastric reduction or remodeling is described.Inamed Corporation of Santa Barbara, Calif., markets the BioEnterics®LAP-BAND® System, which consists of an inflatable silicone band that islaparascopically placed within a patient's abdomen. The band is fastenedaround the upper stomach, giving the stomach an hourglass profile andcreating a tiny stomach pouch that limits and controls an amount of foodthe patient can ingest. It also creates a small outlet that slows theemptying process into the stomach and the intestines. According to thecompany's website, patients using the system experience an earliersensation of fullness and are satisfied with smaller amounts of food,which results in weight loss.

[0269] A significant drawback of the BioEnterics® LAP-BAND® System isthat a laparascopic incision must be made within the patient's abdomenin order to place the device. Applicant's co-pending U.S. patentapplication Ser. No. 10/288,619, which is incorporated herein byreference in its entirety, and from which the present application claimspriority, describes endoluminal methods and apparatus for providing thestomach with an hourglass profile to facilitate weight loss, therebymitigating a need for laparascopic incisions. In FIGS. 43, a system oftools of the present invention is used to endoluminally achieve suchgastric reduction or remodeling via plicated tissue folds. In the methodof FIGS. 43, only suture is disposed on the exterior of the stomachpost-reduction/remodeling.

[0270] In FIG. 43A, a plurality of tissue folds F have been formedaround the circumference of stomach S within an upper portion of thestomach via a system of tools comprising plication apparatus 10, aplurality of anchor assemblies 60 interconnected by suture 39,multi-fire anchor delivery system 500, shape-lockable apparatus 1000 andgastroscope 1100. In FIG. 43B, the interconnected anchor assemblies havebeen cinched together, thereby approximating the plurality of tissuefolds F, and endoluminally providing stomach S with an hourglassprofile. The system of tools may then be removed from the patient,thereby completing endoluminal reduction or remodeling of stomach S.

[0271] In FIGS. 40-42, as an alternative to using anchor delivery system250 of FIGS. 21, a multi-fire anchor delivery system, such as anchordelivery system 500, 500′ or 600 of FIGS. 25-27 (loaded, for example,with multiple anchor assemblies 60 of FIGS. 7), may be used so as toomit a need to remove and reload all or a portion of the anchor deliverysystem from the patient's GI lumen in order to deploy and securemultiple anchor assemblies across one or more tissue folds. Furthermore,although the methods of FIGS. 40-43 have illustratively been describedwith reference to a system of tools comprising plication apparatus 10,anchor assembly 60, anchor delivery system 250 (delivery system 500 inFIG. 43), shape-lockable apparatus 1000 and gastroscope 1100, anycombination of diagnostic or therapeutic tools/instruments in accordancewith the present invention may be utilized, including, for example,alternative plication apparatus, anchor assemblies, anchor deliverysystems and shape-lockable apparatus described previously. Furtherstill,although the visualization element described in FIGS. 40-43 comprises anendoscope or gastroscope, it should be understood that any otheralternative or additional methods or apparatus for visualizing a medicalprocedure may be provided, including, but not limited to, magneticresonance imaging, ultrasound imaging, optical coherence tomographyimaging, fluoroscopic imaging, and combinations thereof. Also, althoughthe system of tools have illustratively been described as advancedthrough shape-lockable apparatus 1000, it should be understood that anyor all of the tools alternatively or additionally may be coupled toapparatus 1000, for example, to distal region 1003 of apparatus 1000.

[0272]FIGS. 40-43 have presented methods of using apparatus of thepresent invention to perform endoluminal gastric reduction and treatmentof GERD. Alternative methods for performing these medical proceduresusing apparatus of the present invention will be apparent to those ofskill in the art. For example, U.S. Pat. No. 6,540,789 to Silvermann etal., which is incorporated herein by reference, describes a method forperforming gastric reduction by injecting bulking agents into apatient's stomach at a plurality of locations, thereby reducing a volumeof the stomach. Apparatus of the present invention may be used to reducethe volume of a patient's stomach by forming a plurality of securedtissue folds within the stomach. The tissue folds may be formed, forexample, at a plurality of randomly selected locations. Alternatively,apparatus of the present invention may be used to perform gastricreduction via placement and/or sizing of an implantable stoma within thestomach. As yet another example, marking devices may be provided withapparatus of the present invention in order to map out locations forformation of tissue folds, e.g., to achieve gastric reduction.Additional methods will be apparent.

[0273] Apparatus of the present invention should in no way be construedas limited to treatment of GERD or morbid obesity. Rather, a variety ofother medical procedures—both diagnostic and therapeutic, or acombination thereof—may be performed within a patient's gastrointestinallumen or other body cavities or organs, including hollow, tortuousand/or unpredictably supported body cavities, using tools andinstruments of the present invention. These include, but are not limitedto, endoscopic retrograde cholangiopancreatography (“ERCP”), intubationof the bile duct, upper or lower gastrointestinal endoscopy,colonoscopy, flexible sigmoidoscopy, esophageal dilatation, anastomosis,liver biopsy, esophageal manometry, esophageal pH, cholecystectomy,enteroscopy, resection of lesions or early cancers, treatment ofbleeding sites, trans-esophageal microsurgery, trans-anal microsurgery,and combinations thereof. Additional procedures will be apparent tothose of skill in the art.

[0274] With reference to FIG. 44, an exemplary method of resecting alesion or early cancer, e.g. within a patient's gastrointestinal tract,using apparatus of the present invention is described. In FIG. 44,system of tools 3000 comprises shape-lockable overtube 1000 havingsuction plicator 1500 coupled to its distal end. System 3000 furthercomprises endoscope 1100 and tool delivery tube 1600 disposed withinlumen 1005 of overtube 1000. Tool delivery tube 1600 optionally maycomprise delivery tube 252 of anchor delivery system 250, as describedhereinbelow with respect to FIG. 45, or may comprise the delivery tubeof any alternative anchor delivery system described previously.Furthermore, tube 1600 may be coupled to overtube 1000 or mayadvanceable relative to the overtube.

[0275] Suction plicator 1500 comprises side aperture 1510 to facilitateside-suction plication of tissue. Plicator 1500 additionally oralternatively may comprise one or more apertures at its distal end (notshown) to facilitate end-suction plication of tissue. Plicator 1500 andovertube 1000 preferably are sealed along their lengths, such thatsuction may be drawn through the overtube and plicator, e.g., via asuction pump (not shown) coupled to a proximal region of overtube 1000external to the patient.

[0276] Advantageously, as compared to previously-known suction plicationapparatus, shape-lockable overtube 1000 allows system of tools 3000 tobe positioned at a treatment site while the overtube is disposed in aflexible state. Overtube 1000 then optionally may be transitioned to arigid state prior to drawing of suction through plicator 1500. In thismanner, system 3000 may be directed to, and maintained at, a treatmentsite during a medical procedure.

[0277] In FIG. 44, shape-lockable overtube 1000 has been endoscopicallyadvanced, e.g., through a patient's esophagus or colon, under endoscopicvisualization provided by endoscope 1100, to a vicinity of lesion orearly cancer C along tissue wall W, while the overtube was disposed in aflexible state. Overtube 1000 alternatively may be advancedlaparascopically, e.g. through a trocar. The overtube preferably is thentransitioned to a rigid state in a configuration enabling access, e.g.luminal access, to the lesion or early cancer.

[0278] Suction is drawn through overtube 1000 and suction plicator 1500to urge tissue in the vicinity of lesion/early cancer C through sideaperture 1510 and into lumen 1005 of overtube 1000, thereby formingtissue fold F. As can be verified by endbscopic visualization, lesion orcancer C resides on the folded tissue. The lesion, polyp, cancer, etc.then may be removed via cutting apparatus, such as snare or resectionloop 1700 advanced through tool delivery tube 1600. As will be apparentto those of skill in the art, alternative plication apparatus inaccordance with the present invention may be used to resect lesion C.

[0279] With reference now to FIG. 45, an exemplary method forendoscopically treating a bleeding site, e.g. within a patient'sgastrointestinal tract, is described. In FIG. 45, system of tools 3000′is substantially the same as system 3000 of FIG. 44, except that tooldelivery tube 1600′ illustratively comprises delivery tube 252 of anchordelivery system of 250, and resection loop 1700 illustratively has beenreplaced with anchor delivery system 250 and anchor assembly 60 forsecuring tissue folds drawn through side-aperture 1510 of suctionplicator 1500. System 3000′ has been positioned, and tissue fold F hasbeen formed, utilizing the techniques described hereinabove with respectto FIG. 44, such that bleeding site B resides on folded tissue F. Anchordelivery system 250 having needle 260 is then actuated in the mannerdescribed previously to deploy and adjust anchor assembly 60 and securetissue fold F, thereby sealing and precluding additional bleeding frombleeding site B.

[0280] As will be apparent to those of skill in the art, alternativeplication apparatus and/or anchor delivery systems in accordance withthe present invention may be used to treat bleeding site B. Furthermore,although tool systems 3000 and 3000′ of FIGS. 44 and 45, respectively,have illustratively been described for use in resecting lesions and/ortreating bleeding sites, these systems alternatively or additionally maybe used for any other applicable medical procedure, including, but notlimited to, those described previously, such as gastric reduction andtreatment of gastroesophageal reflux disease.

[0281] Although preferred illustrative embodiments of the presentinvention are described hereinabove, it will be apparent to thoseskilled in the art that various changes and modifications may be madethereto without departing from the invention. It is intended in theappended claims to cover all such changes and modifications that fallwithin the true spirit and scope of the invention.

What is claimed is:
 1. A system for performing a medical procedure within a hollow body organ of tortuous or unpredictably supported anatomy, the system comprising: a shape-lockable guide; and a plication device.
 2. The system of claim 1 further comprising: an anchor delivery system; and at least one anchor.
 3. The system of claim 1 further comprising a visualization element.
 4. The system of claim 1, wherein the shape-lockable guide is chosen from the group consisting of shape-lockable overtubes, shape-lockable guide wires, shape-lockable inner conduits, and combinations thereof.
 5. The system of claim 1, wherein the plication device comprises a tissue engaging assembly.
 6. The system of claim 2, wherein the anchor delivery system is adapted to deliver a plurality of anchors without necessitating reloading.
 7. The system of claim 2, wherein the anchor delivery system is adapted for reloading without completely removing the anchor delivery system from the patient.
 8. The system of claim 3, wherein the visualization element is chosen from the group consisting of magnetic resonance imaging apparatus, ultrasound imaging apparatus, optical coherence tomography imaging apparatus, fluoroscopic imaging apparatus, endoscopes, colonoscopes, gastroscopes, laparascopes, fiberscopes, videoscopes and combinations thereof.
 9. The system of claim 1, wherein the medical procedure is chosen from the group consisting of diagnostic medical procedures, therapeutic medical procedures, treatment of gastroesophageal reflux disease, gastric reduction, endoscopic retrograde cholangiopancreatography, intubation of the bile duct, upper gastrointestinal endoscopy, lower gastrointestinal endoscopy, colonoscopy, flexible sigmoidoscopy, esophageal dilatation, anastomosis, liver biopsy, esophageal manometry, esophageal pH, cholecystectomy, enteroscopy, resection of lesions, resection of cancers, treatment of bleeding sites, trans-esophageal microsurgery, trans-anal microsurgery, and combinations thereof.
 10. Apparatus for performing a medical procedure within a hollow body organ of tortuous or unpredictably supported anatomy, the apparatus comprising: an overtube having a flexible state that facilitates insertion of the overtube into the hollow body organ, and a rigid state wherein the overtube resists bending forces exerted on the overtube; a mechanism selectively operable to reversibly transition the overtube between the flexible and rigid states; and a device adapted to form tissue folds within the hollow body organ, wherein the device may be advanced through the overtube while the overtube is disposed in the rigid state in any desired configuration within the unpredictably supported anatomy.
 11. The apparatus of claim 10 further comprising a visualization element.
 12. Apparatus for performing a medical procedure within a hollow body organ of tortuous or unpredictably supported anatomy, the apparatus comprising: a main body having a flexible state that facilitates insertion of the main body into the hollow body organ, and a rigid state wherein the main body resists bending forces exerted on the main body; a mechanism selectively operable to reversibly transition the main body between the flexible and rigid states while the main body is disposed in any desired configuration; and a device coupled to a distal region of the main body, wherein the device is adapted to form tissue folds within the hollow body organ.
 13. The apparatus of claim 12 further comprising a visualization element.
 14. Apparatus for plicating tissue within a hollow body organ of tortuous or unpredictably supported anatomy, the apparatus comprising: a guide tube; a visualization device; and at least one therapeutic device, wherein the visualization device and the at least one therapeutic device are configured for passage through the guide tube.
 15. The apparatus of claim 14, wherein the visualization device comprises an endoscope.
 16. The apparatus of claim 14, wherein the guide tube is shape-lockable.
 17. The apparatus of claim 14, wherein the at least one therapeutic device comprises a tissue engaging assembly.
 18. The apparatus of claim 14, wherein the at least one therapeutic device comprises a tissue plicator.
 19. The apparatus of claim 14, wherein the guide tube is adapted to provide the visualization device and the at least one therapeutic device with exposure, stability and flexibility.
 20. The apparatus of claim 14, wherein the guide tube comprises first and second lumens, the visualization device configured for passage through the first lumen and the at least one therapeutic device configured for passage through the second lumen.
 21. A method for performing a medical procedure within a hollow body organ of tortuous or unpredictably supported anatomy, the method comprising: advancing an overtube within the hollow body organ in a flexible state; transitioning the overtube to a rigid state in any desired configuration; advancing a plication device through the overtube; and forming a tissue fold within the hollow body organ with the plication device.
 22. The method of claim 21 further comprising visualizing formation of the tissue fold.
 23. The method of claim 22, wherein visualizing formation of the tissue fold further comprises visualizing formation with a visualization element advanced through the overtube.
 24. The method of claim 22, wherein visualizing formation of the tissue fold further comprises visualizing formation with a visualization element coupled to the overtube.
 25. The method of claim 21, wherein the medical procedure comprises endoscopically treating gastroesophageal reflux disease, advancing the overtube within a hollow body organ comprises advancing the overtube through a patient's esophagus and into the patient's stomach, transitioning the overtube to a rigid state comprises transitioning the overtube to a rigid state in a configuration enabling access to the patient's gastroesophageal junction, and forming a tissue fold comprises forming at least one tissue fold in a vicinity of the patient's gastroesophageal junction.
 26. The method of claim 21, wherein the medical procedure comprises endoscopically performing gastric reduction, advancing the overtube within a hollow body organ comprises advancing an overtube through a patient's esophagus and into the patient's stomach, transitioning the overtube to a rigid state comprises transitioning the overtube to a rigid state in a desired configuration within the patient's stomach, and forming a tissue fold comprises forming a plurality of tissue folds within the patient's stomach.
 27. The method of claim 26 further comprising approximating and securing the plurality of tissue folds, thereby partitioning the patient's stomach into at least first and second chambers over at least a portion of the stomach.
 28. The method of claim 26, wherein forming, approximating and securing a plurality of tissue folds further comprises: forming, approximating and securing a first plurality of tissue folds in a first plane; and forming, approximating and securing at least one additional plurality of tissue folds in at least one additional plane, wherein the first plane and the at least one additional plane are substantially parallel to one another.
 29. The method of claim 27, wherein partitioning the stomach into first and second chambers further comprises partitioning the stomach into a first lumen and a second chamber.
 30. The method of claim 29, wherein partitioning the stomach into a first lumen and a second chamber further comprises partitioning the stomach such that the patient's gastroesophageal junction only communicates with the first lumen.
 31. The method of claim 30, wherein partitioning the stomach into a first lumen comprises partitioning the stomach into a first lumen having a volume in the range of 10-50 cm³.
 32. The method of claim 26, wherein forming a plurality of tissue folds further comprises forming a plurality of tissue folds inferior to the patient's gastroesophageal junction.
 33. The method of claim 32, wherein forming a plurality of tissue folds further comprises forming a plurality of tissue folds having at least one tissue fold from an anterior segment of the patient's stomach and at least one tissue fold from an opposing posterior segment of the patient's stomach.
 34. The method of claim 26, wherein forming a plurality of tissue folds within a patient's stomach comprises forming and securing a plurality of tissue folds disposed at substantially randomly selected locations to reduce a volume of the stomach.
 35. The method of claim 26, wherein forming a plurality of tissue folds within a patient's stomach comprises forming a plurality of interconnected tissue folds around a perimeter of the patient's stomach with instruments advanced through, or coupled to, the overtube, the method further comprising approximating the plurality of interconnected tissue folds to remodel the stomach to an hourglass profile.
 36. The method of claim 21, wherein the medical procedure comprises resecting a lesion or cancer within a patient's gastrointestinal tract, advancing the overtube within a hollow body organ comprises advancing the overtube through the patient's esophagus or colon, transitioning the overtube to a rigid state comprises transitioning the overtube to a rigid state in a configuration enabling access to the lesion or cancer, and forming a tissue fold comprises forming at least one tissue fold with a plication device advanced through, or coupled to, the overtube, so that the lesion or cancer is disposed on the tissue fold.
 37. The method of claim 36 further comprising removing the lesion or cancer.
 38. The method of claim 37, wherein removing the lesion or cancer further comprises removing the lesion or cancer with cutting apparatus.
 39. The method of claim 38, wherein removing the lesion or cancer with cutting apparatus further comprises removing the lesion or cancer with a snare.
 40. The method of claim 21, wherein the medical procedure comprises endoscopically treating a bleeding site within a patient's gastrointestinal tract, advancing the overtube within a hollow body organ comprises advancing the overtube through the patient's esophagus or colon, transitioning the overtube to a rigid state comprises transitioning the overtube to a rigid state in a configuration enabling access to the bleeding site, and forming a tissue fold comprises forming at least one tissue fold with a plication device advanced through, or coupled to, the overtube, so that the bleeding site is disposed on the tissue fold.
 41. The method of claim 40 further comprising securing the tissue fold, thereby reducing bleeding from the bleeding site.
 42. The method of claim 41, wherein securing the tissue fold further comprises securing the tissue fold with an anchor assembly.
 43. A method for performing a medical procedure within a hollow body organ of tortuous or unpredictably supported anatomy, the method comprising: advancing a main body within the hollow body organ in a flexible state, the main body having a plication device coupled to a distal region thereof; transitioning the main body to a rigid state in any desired configuration; and forming a tissue fold within the hollow body organ with the plication device.
 44. The method of claim 43 further comprising visualizing formation of the tissue fold.
 45. The method of claim 44, wherein visualizing formation of the tissue fold further comprises visualizing formation with a visualization element advanced through the overtube.
 46. The method of claim 44, wherein visualizing formation of the tissue fold further comprises visualizing formation with a visualization element coupled to the overtube.
 47. The method of claim 43, wherein the medical procedure comprises endoscopically treating gastroesophageal reflux disease, advancing the main body within a hollow body organ comprises advancing the main body having a plication device coupled to a distal region thereof through a patient's esophagus and into the patient's stomach, transitioning the main body to a rigid state comprises transitioning the main body to a rigid state in a configuration that provides for engagement of tissue in a vicinity of the patient's gastroesophageal junction with the plication device, and forming a tissue fold comprises forming at least one tissue fold in the vicinity of the patient's gastroesophageal junction.
 48. The method of claim 43, wherein the medical procedure comprises endoscopically performing gastric reduction, advancing the main body within a hollow body organ comprises advancing a main body having a plication device coupled to a distal region thereof through a patient's esophagus into the patient's stomach, transitioning the main body to a rigid state comprises transitioning the main body to a rigid state in a desired configuration within the patient's stomach, and forming a tissue fold comprises forming a plurality of tissue folds within the patient's stomach.
 49. The method of claim 48 further comprising approximating and securing the plurality of tissue folds, thereby partitioning the patient's stomach into at least first and second chambers over at least a portion of the stomach. 